Europe's Evolving Regulatory Strategy for GMOs â•fi The

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Europe's Evolving Regulatory Strategy for GMOs – The Issue of Europe's Evolving Regulatory Strategy for GMOs – The Issue of

Consistency with WTO Law: Of Kine and Brine Consistency with WTO Law: Of Kine and Brine

Robert Howse

Petros C. Mavroidis Columbia Law School, [email protected]

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EUROPE'S EVOLVING REGULATORYSTRATEGY FOR GMOS-THE ISSUE OF

CONSISTENCY WITH WTO LAW:OF KINE AND BRINE

Robert Howse& Petros C. Mavroidis*

INTRODUCTION

This Essay deals with one question: If challenged, howwould regulatory restrictions on genetically modified organisms("GMOs") be judged by a World Trade Organization' ("WTO")adjudicating body. Many of the controversies about the effect ofWTO law on domestic regulation have been influenced by theview that the law as it stands may well impede the ability of gov-ernments to regulate new and uncertain risks to health and theenvironment. The result in the Beef Hormones case ("Hormonescase") is often cited for this proposition. In this Essay we aim toshow that, contrary to an increasingly widespread popular per-ception, if WTO law is properly interpreted, GMO-related mea-sures, where non-discriminatory against other WTO Members,can pass the test of consistency with even the most stringent ofrelevant WTO rules.

Since it is real world regulations that are actually subject tochallenge in WTO dispute settlement, we have chosen the evolv-ing approach in the EU to the regulation of GMOs in order toillustrate this proposition. It is EU regulation, and U.S. objec-tions to it, that have made GMOs a high profile trade issue, inthe first place. And European regulation is explicitly and self-consciously based on a precautionary or conservative approachto new or not well known risks. Finally, the EU has one of thefew already highly developed regulatory regimes for GMOs.

In Part I, we provide a brief account of the potentially rele-

* University of Michigan and University of Neuchatel and CEPR respectively. The

authors would like to cordially thank Henrik Horn af Rantzien, Joost Pauwelyn, Lo-renzo Sigismondi, Michael Trebilcock, Julie Soloway, Lisi Tuerck, and Rick Lempert forvery helpful discussions.

1. Marrakesh Agreement Establishing the World Trade Organization, Annex IC,LEGAL INSTRUMENTS-RESULTS OF THE URUGUAY ROUND vol. 1, 33 I.L.M. 1125 (1994)[hereinafter WTO Agreement].

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vant WTO Agreements that can be used as a benchmark in ex-amining the consistency of GMO-related measures. We con-clude, for reasons explained in the section, that the WTO Agree-ment on the Application of Sanitary and PhytosanitaryMeasures2 ("SPS") is the forum that will in all likelihood enter-tain challenges against measures prohibiting or limiting the useof GMOs. In Part II we provide an account of the WTO case-lawon the SPS Agreement. In this section, we aim to clarify what theAppellate Body and Panels have stated so far when dealing withSPS-related issues. We apply the dicta in Part III to GMO-relatedmeasures and in the final section we conclude.

I. WTO PROVISIONS APPLICABLE TO GMOS

A. In General: The Three Musketeers

The WTO contract, with some notable exceptions like theAgreement on Trade Related Intellectual Property Rights3

("TRIPS"), is not about regulatory harmonization. The tradi-tional paradigm between the WTO and General Agreement onTariffs and Trade ("GATT") is essentially that WTO membersare free to enact their domestic policies.4 Such policies, to theextent that they might affect trade flows (actually or potentially,as standing GATT-WTO case-law has made it clear), will bejudged WTO-compatible if they respect the non-discriminationprinciple and are enacted and applied transparently and non-arbitrarily, so as to avoid hidden or embedded protectionism.

This point was made clear in the recent notorious Shrimp-Turtle litigation where the Appellate Body ruled that condition-ing market access to prior adoption of domestic policies is not

2. Agreement on the Application of Sanitary and Phytosanitary Measures, Apr. 15,1994, WTO Agreement, Annex IA, at http://www.wto.org/english/docs-e/legal-e/fi-nal_e.htm [hereinafter SPS Agreement].

3. Agreement on Trade-Related Aspects of Intellectual Property Rights, Apr. 15,

1994, WTO Agreement, Annex IC, LEGAL INSTRUMENTS-RESULTS OF THE URUGUAY

ROUND vol. 31, 33 I.L.M. 1197 (1994) [hereinafter TRIPS].

4. See Frieder Roessler, Increasing Market Access Under Regulatory Heterogeneity, in REG-ULATORY REFORM AND INTERNATIONAL MARKET OPENNESS: OECD PROCEEDINGS 117-30

(1996); see also David Leebron, Lying Down with Procrustes: An Analysis of HarmonizationClaims, in FAIR TRADE AND HARMONIZATION: PREREQUISITES FOR FREE TRADE? 41, 65 (.Bhagwati & R.E. Hudec eds., 1996); Michael J. Trebilcock & Robert Howse, Trade Liber-alization and Regulatory Diversity: Reconciling Competitive Markets with Competitive Politics, 6EUR. J.L. & ECON. 5, 21-22 (1998).

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per se inconsistent with the WTO rules.5 However, some earlierGATT jurisprudence has suggested measures that are non-dis-criminatory with respect to the country of origin of products thatmay nevertheless violate Article XI of the GATT and/or the non-discrimination principle in Article III of the GATT, if they treatproducts differently on the basis of the manner in which they areproduced.6 However, as the Appellate Body has stressed in an-other case, depending on the non-discrimination provision at is-sue and the regulatory context, a wide range of factors may berelevant to distinguish products as "unlike."7 Let us take the ex-ample of a WTO Member that wishes to distinguish the treat-ment of maize from that afforded to GMO-maize for health rea-sons. A WTO Member adopting its health policy might be mak-ing distinctions between two otherwise "like or directlycompetitive products" and thus violate its obligations underGATT Article III (national treatment). In such a case, an appro-priate reading of Article 111(4) of the GATT would accept that

5. See United States-Import Prohibition of Certain Shrimp and Shrimp Products, Reportof the Appellate Body, WT/DS58/AB/R (Oct. 12, 1998). The point that WTO rulesapply on a context of regulatory diversity has been subsequently confirmed. See UnitedStates-Tax Treatment for Foreign Sales Corporations, Report of the Appellate Body, WT/DS108/AB/R (Feb. 8, 2000). It should be noted that the outcome reached in the twocited reports is perfectly compatible with public international law, amounting to theproposition that no transfer of national sovereignty to the international plane shouldbe presumed.

6. See, e.g., United States-Restrictions on Imports of Tuna, DS21/R (Sep. 3, 1991) (not

adopted) and DS29/R (Jun. 16, 1994) (not adopted).7. Japan-Taxes on Alcoholic Beverages, Report of the Appellate Body, WT/DS8/AB/

R (Oct. 4 1996). See also Chile-Taxes on Alcoholic Beverages, Report of the Appellate Body,WT/DS1lO/AB/R (Dec. 13, 1999). However, a panel recently came to the conclusionthat WTO Members could not, consistent with the National Treatment Obligation, dis-tinguish between products based on their harmfulness to human health. European Com-munities-Measures Affecting Asbestos and Asbesetos-Containing Products, Report of thePanel, WT/DS135/R (Sept. 18, 2000). This finding has now been reversed by the Ap-pellate Body, which has held that the health effects of products may be relevant to theanalysis of whether they are "like," both in terms of physical characteristics and con-sumer perceptions and behavior. Whatever the "physical" differences between GM andnon GM food products, there is a great deal of evidence that many consumers perceive

these as "unlike." The Appellate Body also held that even where two products are con-sidered "like," they can still be distinguished in regulations, provided the distinction inquestion does not result in the protection of domestic production. European Communi-ties-Measures Affecting Asbestos and Asbestos-containing Products, Report of the AppellateBody, AB-2000-11, (Mar. 12, 2001). On the flimsy legal basis for the product/processdistinction in GATT law and jurisprudence and the implications of the Japanese Alcoholcase for that distinction, see Robert Howse & Donald Regan, The Product/Process Distinc-tion-An Illusory Basis for Disciplining "Unilateralism" in Trade Policy, II EUR. J. INT'L. L.249 (2000).

320 FORDHAM INTERNATIONAL LAWJOURNAL [Vol. 24:317

these products are "unlike," if only because there are differencesbetween them that will likely matter a great deal from the per-spective of the consumer. Moreover, the products are being dis-tinguished based on the operational requirements of a non-pro-tectionist scheme for health regulation, and there is no elementof discrimination between domestic products and imports builtinto the distinction in question-domestically-produced GMO-maize is treated no better nor worse than imported GMO-maize.'

Moreover, the WTO paradigm does not make even the non-discriminatory principle into an absolute. Thus, even wherefound to be discriminatory, in some cases, a Member's policiescould be justified under Article XX, for example as necessary forthe protection of human or animal life or health XX(b). This issubject to the general proviso, the "chapeau" of Article XX, thatsuch policies not be applied in such a manner as to constitutearbitrary or unjustified discrimination between countries wherethe same conditions prevail, or a disguised restriction on inter-national trade. Article XX of GATT is one possible forum toentertain GMO-related issues; this could happen if elements ofdiscrimination between imports and domestic products werefound to be built into a Member's approach to GMO regulation.As the Appellate Body emphasized in Japanese Alcohol, the factorsthat may distinguish like from unlike products are open-ended,and the analysis of likeness is fact-intensive and must be done ona case-by-case basis. Thus, it is far from unimaginable that theAppellate Body might find that some distinctions in a Member'soverall scheme for regulating GMOs result in less favourabletreatment of "like products," as opposed to differential treat-ment of products that are "unlike." This would depend on adetailed examination of scientific and regulatory facts.

The Agreement on Technical Barriers to Trade9 ("TBT") isanother possible WTO forum for the examination of GMO-re-

8. In the real word, unlike this simplified example, it is not always easy to discernwhether there might be protectionist or discriminatory elements built into an appar-ently neutral scheme and its application. This is a major rationale for the sanitary andphytosanitary ("SPS") provisions that we will discuss in due course, which impose partic-ular disciplines on the regulatory process, even where the overall scheme may well benon-discriminatory.

9. Agreement on Technical Barriers to Trade, Apr. 15, 1994, WTO Agreement,Annex IA, at http://www.wto.org/english/docs.e/legalfe/final-e.htm [hereinafterTBT Agreement].

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lated regulations: A WTO Member could very well, through en-actment of a technical regulation in accordance with Article 2.2of the TBT, provide for compulsory labelling of all GMO-treatedgoods. In such a case, if challenged, the WTO Member at handwill have to demonstrate (provided of course, that the com-plaining party has absolved its burden of proof) that it respectedthe TBT disciplines when enacting its labelling requirements.

Finally, to the extent that the WTO Member adopts a sani-tary or phytosanitary measure (fearing for example, the spreadof a disease through importation of GMO-treated goods) itmight be called to justify its policies under the SPS Agreement.

If the test in all three Agreements (GATT, TBT, and SPS)was identical, the question of whether to subordinate GMO-re-lated concerns would beimmaterial. This is hardly the casethough. Except for temporary or provisional measures, the SPSAgreement is the only one that requires that regulations bebased on scientific evidence. Consequently, in what follows weexamine the relationship between the three Agreements.

B. TBT andSPS

The relationship between the TBT and the SPS Agreementsis at first glance quite clear: Article 1.5 of the TBT provides thatthe provisions of the TBT Agreement do not apply to measuresdefined as Sanitary and Phytosanitary Measures in Annex A ofthe SPS Agreement. The definition of Annex A is broad, andincludes almost all relevant measures to protect human oranimal health, life, or the envii'onment, generally arising fromimportation of foods and agricultural products. Essentially allexisting GMO-related regulation in developed countries is char-acterized in this fashion, and thus one can confidently say thatSPS applies exclusively. However, ethical rationales have some-times been stated for restrictions on genetic engineering, as wellas rationales connected to the social economy required to pre-serve indigenous agriculture and traditional ways of life. Whereregulations are explicitly addressed to these purposes, the appli-cation of SPS exclusively may need to be reconsidered.

C. SPS and Article XX of GATT: An Issue

The relationship between Article XX of GATT and the SPSAgreement has not been clarified in the WTO case-law as of yet.

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This is due to a number of reasons. First, the General Interpre-tative Note, which regulates the relationship between GATT andits annexed Agreements (both the TBT and the SPS are an-nexed to GATT), has not been scrutinized with sufficient preci-sion by WTO adjudicating bodies. The fact that the Panel Re-port Indonesia-and Certain Measures Affecting the Automobile Indus-ty,10 which discussed in extenso the General Interpretative Note,ultimately, was not appealed has not been helpful.

Second, assuming arguendo that the General InterpretativeNote is to be interpreted in light of the lex specialis rule, we note:The maxim of lex specialis is not a model of clarity. Bartels notesthat the maxim dates, at the latest, from Grotius who believedthat "special provisions are ordinarily more effective than thosethat are general." The maxim, however, was never reflected inthe Vienna Convention on the Law of Treaties, which codifiescustomary international law with respect to interpretation oftreaties. This fact alone casts doubt as to the pertinence and theambit of the principle.

Arguably, the principle can have value if viewed in the con-text of effective treaty interpretation. Viewed from this angle,the argument runs as follows: If the same factual situation canbe submitted to two different treaty provisions that contain dif-ferent tests, it is almost certain that plaintiffs will challenge mea-sures under the relatively more stringent test for the defendant.Hence, in as much as the jurisprudence is clear on which stan-dard gives the plaintiff an advantage, there are good chancesthat the relatively relaxed standard will fall in desuetudo. The in-terpreter can avoid such an outcome by carefully circumscribingthe ambit of lex specialis, which is, in the Grotian sense, the moreeffective rule, and prescribing applicability of the more generalrule to the extent that there is no overlap, or more generally, asevidence of the "spirit" of the special rule.

We should note, however, that an interpretation of the lexspecialis maxim in the light of the principle of effective treatyinterpretation has not been accepted (nor rejected) as yet in thecontext of WTO case-law. Hence, the question as to which of theSPS Agreement and Article XX of GATT prevails remains unan-swered at the positive level. At the same time, lex specialis, cast in

10. Indonesia-Certain Measures Affecting the Automobile Industry, Panel Report, WT/DS54/AB/R Uuly 2, 1998).

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terms of effective treaty interpretation, is closely related to judi-cial economy, a principle of adjudication endorsed by the Appel-late Body." The idea of lex specialis is also consistent with theAppellate Body's emphasis on the duty of a treaty interpreter toconsider all the relevant words of the treaty. Where a generalstandard or norm is embodied in a more specific treaty text, afailure to consider the more specific terms would be a derelic-tion of this duty. On the other hand, to the extent that the moregeneral standard or norm is adequately embodied in the morespecific text, the principle ofjudicial economy, and more gener-ally of effective treaty interpretation, would seem to militateagainst a further application of the general norm or standarditself, once the more specific text has been applied.

D. SPS and Article XX of GATT: An Issue Yes, But Does It Matter?

So far we established that there is no doubt that the SPSAgreement applies to the exclusion of the TBT Agreement andthat it is not clear that the SPS Agreement prevails over GATT. 12

We submit next that the relationship between Articles III andXX of GATT and the SPS Agreement can in practice be a non-issue in order to justify our conclusion to examine the consis-tency of GMO-related issues within the SPS Agreement only.

As noted above, the SPS Agreement is the only WTO instru-ment that imposes on WTO Members the obligation to basetheir measures on scientific evidence, regardless of whether themeasures are discriminatory or violations of other basic provi-sions of GATT. This extra obligation in fact imposes a higherjustificatory burden on all WTO Members wishing to protectthemselves from GMOs and at the same time makes it easier forpotential complaining parties to challenge them. Hence, itshould be expected that GMO-related measures will in all likeli-hood be challenged as being inconsistent with the SPS Agree-

11. See generally United States-Import Prohibition of Certain Shrimp and Shrimp Prod-ucts, Report of the Appellate Body, WT/DS58/AB/R (Oct. 12, 1998); Japan-Taxes onAlcoholic Beverages, Report of the Appellate Body, WT/DS8/AB/R (Oct. 4, 1996); DavidPalmeter & Petros Mavroidis, The WfO Sources of Law, 92 AM.J. INT'L L. 398413 (1998).

12. In our discussion we assume of course that the complaining party has not de-

cided to challenge a GMO-related measure only under one agreement. In such a case,all our discussion is irrelevant since the WTO adjudicating body will have to entertain aclaim as presented to it. As we show, however, chances are that complaining parties willchoose to invoke the SPS Agreement.

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ment. Here, because the strictures appear to go significantly be-yond the non-discrimination requirement at the core of what wehave called the traditional GATT/WTO paradigm, the proposi-tion to be challenged in this Essay takes on the greatest plausibil-ity. At the same time, it must be understood that it is up to thecomplaining party to prove a violation of a WTO Agreement-thus the complainant would have to at least raise a presumptionthat the Member's GMO related regulations were not based onscientific evidence. In some cases, it could be easier for the com-plainant to raise a presumption that the non-discriminationprinciple in Article 111(4) has been violated, and then force thedefendant to justify its measures scientifically as "necessary"within the meaning of Article XX(b). Take for instance, a banon GMOs originating from a defined list of countries that aredeemed not to have adequate risk management strategies inplace. Since, in such a case, a violation of Articles I and III ofGATT is obvious, by going the GATT XX route, the complainantforces the defendant to bear thejustificatory burden for its mea-sures. Whereas if the SPS route were taken, the complainant inthe first instance would have to show-or raise a presumption-that the defendant's measures were not scientificallyjustified. Inan area such as GMOs, where the science is complex and thereare many uncertainties, one could not entirely dismiss the attrac-tiveness to a complainant of a litigation strategy that requires theexercise of justification by the defendant.

This being said, most of the trade controversy surroundingGMO regulations is not focussed on explicitly discriminatoryregulations, but instead on general regulatory schemes, faciallyapplicable on equal terms to both domestic products and im-ports regardless of country of origin. Thus, determining underArticle 111(4) whether the measures are discriminatory, will in-volve evaluating subtler claims concerning elements of discrimi-nation against imports built into facially neutral regulation.Here, the real issue is the possibility of hidden or structurallyembedded protection. The concepts of "like" products and "lessfavourable treatment" in Article 111(4), even as clarified by theAppellate Body recently in the EC-Asbestos case, provide substan-tially less guidance for drawing the delicate line between inno-cent non-discriminatory regulation and facially neutral, but co-vertly and/or structurally discriminatory measures (which violateArticle 111(4)), than the detailed procedurally-oriented disci-

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plines of SPS, which require that we be able to see into the regu-latory process and ascertain its non-protectionist bona fides.13 Insum, if the adjudicator were to do a good job in dealing withthese kinds of measures under Article 111(4), she would need thekind of tools supplied in SPS. And in turn, once she has usedthese tools, the need for a separate analysis under 111(4) and XXwill be superfluous. Facially-neutral measures that pass musterunder all the explicit disciplines of SPS could not plausibly beshown by a complainant on the balance of probabilities to be aviolation of Article 111(4). The complainant loses no legitimatelitigation advantage by the adjudicator then on the basis of theeffectiveness of treaty interpretation and judicial economy notproceeding to the GATT claim.

These various considerations follow from the basic choice inWTO for a complainant-driven dispute settlement process. TheWTO Agreement does not describe an institution that resemblesthe avis consultatifs that a U.N. organ can request from the Inter-national Court of Justice. In such a case, there would be a shiftin the initiative and hence one could well imagine that a WTOMember wishing to enact a GMO-restraining legislation couldvery well ask questions as to its compatibility with Article XX ofthe GATT.

WTO Members have of course the possibility to request adecision by a WTO Committee. However, as the recent WTOcase-law however makes it clear,' 4 WTO adjudicating bodies arenot bound by decisions of such bodies and will proceed to theirown review independently of what has been decided in the con-text of such Committees. Hence, it will be of little (or no) legalsignificance to WTO Members to initiate a far-fetching discus-sion on GMOs in the context of such Committees.

The only option available left to WTO Members would be torequest an authoritative interpretation of the Agreement or aformal amendment (in accordance with Articles IX and X re-spectively of the WIG Agreement) to the effect that GMO-re-

13. For an analogous discussion of the relationship between Articles III and XXand the TBT Agreement, see Robert Howse & E. Tuerk, The Impact of the WTO on Inter-nal Regulation in the EU, in CONSTITUTIONAL CHANGE IN THE EU (forthcoming 2001).

14. See generally India-Quantitative Restrictions on Imports of Agricultural, Textile andIndustrial Products, Report of the Appellate Body, WT/DS90/AB/R (Apr. 6, 1999); Tur-

key-Restrictions on Imports of Textile and Clothing Products, Panel Report, WT/DS34/R(May 31, 1999).

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straining legislation be judged compatible with the WTO. Suchaction would pre-empt review by WTO adjudicating bodies sincethe latter (agents) would have to respect the will of the former(principals).

Such an initiative, however, has not taken place so far andhence the relevance of the following Sections is clear since weexamine how GMO-related issues would be reviewed in the con-text of the SPS Agreement as interpreted so far. We should notethat in what follows we do not deal with the issue quid in case aninternational agreement banning or restraining the use ofGMOs is signed outside the WTO context and its relevance forWTO purposes is requested. So far, such a dispute (which wouldin fact ask whether the WTO contract should be interpreted asself-contained or not) has not been brought before the WTO.However, opinions on this issue have already been expressed inthe literature.15

II. THE SPS A GRUMENT IN LIGHT OF THEWTO JURISPRUDENC1 6

A. In General

The TBT Agreement itself acknowledges that when a dis-puted measure qualifies as an SPS-measure, the SPS Agreementtakes precedence over the TBT. There is nothing like a compa-rable statement in the WTO Agreement with respect to the rela-tionship between the SPS and Article XX of GATT (or XIVGATS). This is particularly troublesome, since, unlike SPS, Arti-cle XX(b) on its face does not require that health-based mea-sures blocking trade must be based on scientific evidence. Inpractice, however, it would be difficult for the defendant to meetits burden of proof that otherwise illegal GATT measures are"necessary" for the protection of health without some resort toscientific evidence. The fundamental difference between justifi-cation under Article XX(b) and the scientific evidence require-ment in the SPS Agreement is that under Article XX in general,the defendant bears, in the first instance, the burden of prooffor justifying its measures, but (as discussed above) only those

15. SeeJoel P. Trachtman, Decisions of the Appellate Body of the World 7rade Organiza-tion, 9 HARV. J. INT'L L. 551 (1999); Palmeter & Mavroidis, supra note 11.

16. This Section relies on HENRIK HORN & PETROS C. MAVROIDIS, FLASH BACK:

WHAT WERE You THINKING WHEN ENACTING HEALTH POLICIES (2000).

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measures that have already been shown to violate some provisionof GATT.

B. Health Measures and International Standards

Article 3 of the SPS Agreement deals with the relationshipbetween domestic SPS regulations and international standards.There is a general obligation to base domestic SPS measures oninternational standards. This is subject to a right to deviate frominternational standards where the result is a higher level of pro-tection. This right to deviate is in turn conditioned on the re-quirements of scientific risk assessment in the regulatory processthat are detailed in Article 5 of SPS. In addition to measuresbased on international standards and those that deviate from in-ternational standards in accordance with 3.3 in order to achievea higher level of protection, a third category is measures that"conform to" international standards. In the case of the last cat-egory, there is a presumption that the measure at hand is com-patible with the WTO, including that it could be justified underArticle XX of GATT.17 As the Appellate Body noted in MeasuresConcerning Meat and Meat Productsi" ("Hormones"), "conformity"suggests a closer fit than "based on," measures may take interna-tional standards as their point of departure, but reflect consider-able variation at the level of detail, and this is consistent withtheir being "based on" international standards.

In sum, Article 3 of the SPS gives an incentive to states tocomply with international standards but it should not beequated to an obligation to follow them.

The rest of the Essay deals with the case where a WTO Mem-ber has decided to seek a higher level of protection than thatprovided by existing international standards, thereby making itclear that the strictures of Article 5 of the SPS apply.

III. NATIONAL HEALTH STANDARDS

A domestic measure adopted under the SPS must be basedon risk assessment, taking into account scientific evidence.

17. The text of Article 3.2 of the SPS does not make it clear whether the presump-tion established is an irrebutable one.

18. European Communities-Measures Concerning Meat and Meat Products (Hormones),

Report of the Appellate Body, WT/DS26/AB/R (Jan. 16, 1998).

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Moreover, it must be non-discriminatory, 9 in the sense that itwill be applicable in a neutral manner and must also be part of acoherent and consistent policy. Some of the key issues (risk, riskassessment, scientific evidence, non-discrimination, and coher-ence) have been already interpreted in the WTO case law. Wetake them in turn.

A. Must Be Based on a Risk Assessment (Article 5.1 of the SPS)

Logically, for the term "risk assessment" to be interpreted,one must first have a clear idea about what the term "risk" mightmean. It is impossible to speak of a "risk-free" situation, forevery factual situation might entail a certain level of risk. Theexample of incidence of lead in water (that is, how much lead inhow much water is dangerous for a policy prohibiting lead inwater to be addressing a risk) illustrates this point.

The Hormones Appellate Body report acknowledged thispoint (upholding a previous finding by a panel) when it statedthat:

[T]he Panel opposes a requirement of an "identifiable risk"to the uncertainty that theoretically always remains since sci-ence can never provide absolute certainty that a given sub-stance will not ever have adverse health effects. We agree withthe Panel that this theoretical uncertainty is not the kind ofrisk which, under Article 5.1, is to be assessed.9°

However, the Appellate Body also opines that:To the extent that the Panel purported to require a risk as-sessment to establish a minimum magnitude of risk, we mustnote that imposition of such quantitative requirement findsno basis in the SPS Agreement.2 1

We can conclude from the above that a "risk" in the sense ofArticle 5.1 of the SPS must be an ascertainable risk and not themere hypothetical or abstract possibility of risk, which is inher-ent in everyday life precisely because of the limits of human

19. This question must be distinguished from the question whether a demonstra-tion of discrimination is a necessary precondition for invoking the SPS Agreement. It isclear by now that such is not the case, that is, the SPS Agreement comes into playindependently whether discrimination has previously been shown.

20. European Communities-Measures Concerning Meat and Meat Products (Hormones),Report of the Appellate Body, WT/DS26/AB/R (Jan. 16, 1998).

21. Id.

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knowledge. Risk cannot simply be asserted in this general way.There must be some empirical investigation of specific risksThis point has been re-emphasized by the Appellate Body in sub-sequent case law:

As stated in our Report in European Communities-Hor-mones, the risk evaluated in a risk assessment must be an as-certainable risk; theoretical uncertainty is "not the kind ofrisk which, under Article 5.1, is to be assessed. 2 2

We can conclude from the above that a risk in accordancewith Article 5.1 of the SPS must be an ascertainable risk. How-ever, at the same time, once there is empirical evidence of risk, itis perfectly legitimate for a Member to seek to reduce the risk soascertained to zero. Moreover, the notion of ascertainable riskdoes not establish some minimum threshold concerning thelevel of uncertainty or error that is tolerable in a finding of risk.It merely indicates that such a finding must be based on investi-gation consistent with scientific principles, rather than mere unt-ested hypothesis.

Now that we have established what "risk" is, we turn to thenotion of risk assessment. The Hormones Panel Report made adistinction between risk assessment and risk management. Weshould note first that the term "risk assessment" is already de-fined in the SPS Agreement. Annex A contains the followingdefinition:

The evaluation of the likelihood of entry, establishment orspread of a pest or disease within the territory of an import-ing Member according to the sanitary or phytosanitary mea-sures which might be applied, and of the associated potentialbiological and economic consequences; or the evaluation ofthe potential for adverse effects on human or animal healtharising from the presence of additives, contaminants, toxinsor disease-causing organisms in food, beverages or feed-stuffs.

23

The Hormones Panel Report understood this term as follows:"an assessment of risk is, at least for risks to human life or health,

22. Australia-Measures Affecting Impartation of Salmon, Report of the AppellateBody, WT/DS18/AB/R (Oct. 20, 1998) (quoting from European Communities-MeasuresConcerning Meat and Meat Products (Hormones), Report of the Appellate Body, WT/DS26/AB/R (Jan. 16, 1998).

23. SPS Agreement, Annex A.

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a scientific examination of data and factual studies; it is not a pol-icy exercise involving social value judgments made by politicalbodies.

24

The panel distinguishes from "risk assessment," as definedabove, "risk management," which is the second step in a decisionby a WTO Member to enact an SPS measure. That is, after a riskassessment has been carried through, and logically provided thatwe are in presence of an ascertainable risk as defined above,WTO Members can choose their appropriate level of sanitary orphytosanitary protection. 25 As the panel implies, WTO Mem-bers-provided that they respect the disciplines laid out in Arti-cle 5.4-5.6 of the SPS-are free to choose the level of protectionthat seems appropriate to them. This finding is in line with thefinding of the Appellate Body that WTO members can legiti-mately pursue a zero risk-policy. The notion of risk assessmentwas further clarified in the Appellate Body Report on MeasuresAffecting Importation of Salmon.26 There, in an often quoted subse-quent case-law passage, the Appellate Body report holds for thefollowing proposition:

[W] e consider that.., a risk assessment within the meaningof Article 5.1 must:(1) identify the diseases whose entry, establishment or spread

a Member wants to prevent within its territory, as well asthe potential biological and economic consequences as-sociated with the entry, establishment or spread of thesediseases;

(2) evaluate the likelihood of entry, establishment or spread ofthese diseases, as well as the associated potential biologi-cal and economic consequences; and

(3) evaluate the likelihood of entry, establishment or spreadof these diseases according to the SPS measures which might beapplied."

2 7

So, according to this definition, a WTO Member must pro-

24. European Communities-Measures Concerning Meat and Meat Products (Hormones),Complaint by the United States, Report of the Panel, WT/DS26/R/USA (Aug. 18,1997).

25. Surprisingly, the Panel Report does not reflect that the term "appropriate levelof sanitary or phytosanitary protection" has already been interpreted in Annex A in away that essentially condones regulatory diversity.

26. See Australia-Measures Affecting Importation of Salmon, Report of the AppellateBody, WT/DS18/AB/R (Oct. 20, 1998).

27. Id. § 121 (emphasis added).

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vide evidence probative of causal relationship between the SPSmeasure it is about to enact and the disease it wants to address,in the sense that its measure will be the antidote to the identifiedrisks. Moreover, there must be a likelihood of entry of the iden-tified disease, which in turn must be evaluated. The outcome ofsuch evaluation amounts to risk assessment. Likelihood, as theAppellate Body notes, is more than a mere possibility. The Hor-mones Appellate Body Report notes in this respect: "The ordi-nary meaning of 'potential' relates to 'possibility' and is differentfrom the ordinary meaning of 'probability.' 'Probability' impliesa higher degree or a threshold of potentiality or possibility."28

The Salmon Appellate Body report confirmed: "[I] t is notsufficient that a risk assessment conclude that there is a possibilityof entry, establishment or spread of diseases and associated bio-logical and economic consequences. '"29

However, the Appellate Body did not endorse the Panel'smisuse of the statistical concept of probability. It merely re-verted to the notion, developed in Hormones, that a risk must beascertained and defined, rather than being stated in vague termsas a simply possibility-something, that like all events in a un-derdetermined universe, could occur. Hence, we can concludethat, in the relevant Appellate Body case-law, a risk assessment isa process whereby the likelihood of entry of a disease will beascertained.

Now, for an SPS measure to be WTO-compatible it must bebased on a risk assessment. What exactly the words "based on"mean formed the partial subject-matter of the Hormones litiga-tion. Two aspects of the term have been interpreted: the timedimension and the question of overlap between the SPS measureenacted and the risk assessment. We take each issue in turn.

The Panel Report in the Hormones litigation stands for theproposition that "the Member imposing a sanitary measureneeds to submit evidence that at least it actually took into accounta risk assessment when it enacted or maintained its sanitary mea-sure in order for that measure to be considered as based on a riskassessment. "30

28. Id. § 184.29. Id. § 123.30. European Communities-Measures Concerning Meat and Meat Products (Hormones),

Complaint by the United States, Report of the Panel, WT/DS26/R/USA (Aug. 18,1997).

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Hence, according to this view, scientific evidence that didnot serve as the basis for the enactment of the measure can onlybe taken into account if it is shown that the WTO Member some-how considered it either when they first enacted the measure orwhen they re-examined it.31

The Appellate Body reversed the Panel's findings in this re-spect and ruled that scientific evidence can be submitted at alater stage as well. The operative consequence of this ruling isthat a WTO Member can, for the first time, submit that it based ameasure on a risk assessment when challenged before a WTOadjudicating body.32 Hence, according to the prevailing view, aWTO Member can lawfully enact a measure even when it cannotoffer a basis of risk assessment at the moment of enactment ofsuch measure, provided that a basis can be offered, if and whenthe measure is challenged before a VTO adjudicating body.

The Hormones Appellate Body Report, reversing the PanelReport in this respect, made it clear that "based on" should notbe understood to mean that the SPS measure must conform ab-solutely to the risk assessment. A certain margin of discretion infavour of the WTO Member enacting legislation must be ac-knowledged. The relevant passage reads: "[a] measure, how-ever, based on the same standard might not conform to thatstandard, as where only some, not all, of the elements of thestandard are incorporated into the measure. 3

Both the Panel and the Appellate Body Report referred tothe use of international standards. Hence, it is clear that na-tional SPS measures based on international standards can passthe test of WTO legality, even if they reflect only elements of theinternational standard.

B. A Risk Assessment Shall Take Into Account Scientific Evidence(Article 5.2 of the SPS)

The SPS Agreement 34 imposes on all WTO Members con-

31. Id. § 8.115.32. See European Communities-Measures Concerning Meat and Meat Products (Hor-

mones), Report of the Appellate Body, WT/DS26/AB/R (Jan. 16, 1998).33. Id. § 163.34. See generally Joost Pauwelyn, The WFO Agreement on Sanitary and Phytosanitary

(SPS) as Applied in the First Three SPS Disputes, 2 J. INT'L ECON. L. 641 (1999) (providingaccount of all SPS-related cases treated so far by WTO Appellate Body); Robert Howse,

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cerned an obligation to base their measures on scientific evi-dence. In this respect, Article 2.2 of the SPS reads:

Members shall ensure that any sanitary or phytosanitary mea-sure is applied only to the extent necessary to protect human,animal or plant life or health, is based on scientific principlesand is not maintained without scientific evidence, except asprovided for in paragraph 7 of Article 5.

What exactly is scientific evidence?The Hormones Panel Report did not discuss the issue in

great detail. In § 8.130 of the Report though, we note that gen-eral information not relating specifically to the subject matterunder discussion might be disregarded as impertinent. Hence,without explaining exactly which level of specificity is necessaryfor an opinion to qualify as scientific evidence, the panel reportargues in favour of specificity-threshold.

The Hormones Appellate Body report in an often-cited pas-sage tackles another angle with respect to what might constitutescientific evidence. It states:

Article 5.1 does not require that the risk assessment must nec-essarily embody only the view of a majority of the relevantscientific community. In some cases, the very existence of di-vergent views presented by qualified scientists who have inves-tigated the particular issue at hand may indicate a state ofscientific uncertainty. Sometimes a divergence may indicate aroughly equal balance of scientific opinion, which may itselfbe a form of scientific uncertainty. In most cases, responsibleand representative governments tend to base their legislativeand administrative measures on "mainstream" scientific opin-ion. In other cases, equally responsible and representativegovernments may act in good faith on the basis of what, at agiven time, may be a divergent opinion coming from quali-fied and respected sources. 35

Thus, minority scientific opinions by and large suffice for aWTO Member to have met its burden under the SPS.

Further light on the meaning of scientific evidence is pro-vided, indirectly, by the Appellate Body, when examining an oral

Democracy, Science and Free Trade: Risk Regulation on Trial at the WTO, 98 U. MICH. L.R.2329 (2000) (discussing all related cases).


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statement by an expert (Dr. Lucier) invited to testify before it,the Appellate Body notes:

[T] his opinion by Dr. Lucier does not purport to be the re-sult of scientific studies carried out by him or under his super-vision focusing specifically on residues of hormones in meatfrom cattle fattened with such hormones. Accordingly, it ap-pears that the single divergent opinion expressed by Dr. Lu-cier is not reasonably sufficient to overturn the contrary con-clusions reached in the scientific studies referred to by theEuropean Communities that relate specifically to residues ofthe hormones in meat from cattle to which hormones hadbeen administered for growth promotion.3 6

It is unclear why the Appellate Body dismissed the opinionof the expert. The term "accordingly" used by the AppellateBody seems to suggest that the decisive criterion for it to disre-gard the expressed opinion was the fact that Dr. Lucier merelyoffered an oral explanation without having previously conductedresearch on the issue. If this is the case, then the Appellate Bodymost likely rejected the opinion expressed because it did notmeet its self-imposed (but not precise) scientific evidence-thresh-old. In such a case, the Appellate Body implicitly accepts thatsome "minimum methodological requirements" (albeit unde-fined so far) must be there for an opinion to have the status ofscientific evidence. And on the other hand, that if this is thecase, a minority opinion, provided that it meets standard men-tioned above, suffices for a WTO Member to base on it its healthpolicy. But these requirements, rather than residing in someconception of orthodox or mainstream contemporary naturalscience, denote the broader understanding of science as rea-soned inquiry or investigation-a notion reflected in the broad-ness of meaning of the word for "science" in other Europeanlanguages, for example Wissenschaft in German and Nauke inRussian. This is reflected in the following definition of the no-tion of science in the Hormones Appellate Body Report: a processcharacterized by systematic, disciplined and objective enquiryand analysis, that is, a mode of studying and sorting out facts andopinions.""

36. Id. § 198.37. Id. § 187.

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C. What Can be Taken Into Account Beyond Scientific Evidence(Article 5.2 of the SPS)

Article 5.2 of the SPS lists the factors to be taken into ac-count when assessing risk. It mentions available scientific evi-dence; relevant processes and production methods; relevant in-spection, sampling, and testing methods; prevalence of specificdiseases and pests; existence of pest- or disease- free areas; rele-vant ecological and environmental conditions; and quarantineor other treatment.

In a notorious passage in its Hormones Report, the AppellateBody interpreted the objective function of the list:

[T]o the extent that the Panel purports to exclude from thescope of a risk assessment in the sense of Article 5.1, all mat-ters not susceptible of quantitative analysis by the empirical orexperimental laboratory methods commonly associated withthe physical sciences, we believe that the Panel is in error.Some of the kinds of factors listed in Article 5.2 such as "rele-vant processes and production methods" and "relevant in-spection, sampling and testing methods" are not necessarilyor wholly susceptible of investigation according to laboratorymethods of, for example, biochemistry or pharmacology.Furthermore, there is nothing to indicate that the listing offactors that may be taken into account in a risk assessment ofArticle 5.2 was intended to be a closed list. It is essential tobear in mind that the risk that is to be evaluated in a riskassessment under Article 5.1 is not only risk ascertainable in ascience laboratory operating under strictly controlled condi-tions, but also risk in human societies as they actually exist, inother words, the actual potential for adverse effects onhuman health in the real world where people live and workand die.38

Hence, it seems that the Appellate Body in this passage, on

the one hand, opts for a deferential posture to national regula-tors-by allowing WTO Members to view the factors mentionedin the list from the perspective of democratic regulation, notnecessarily from that of laboratory science. On the other hand,the Appellate Body also adopts the position that the list of Arti-cle 5.2 of the SPS is not an exhaustive list and that other factorsnot mentioned in the list could eventually become integral parts

38. Id.

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of the totality of factors that can be taken into account when aWTO Member assesses a risk.

At this stage, the Appellate Body has not yet elaborated onwhich other factors can be taken into account (beyond thosementioned in Article 5.2 of the SPS) or as to how the factorsmentioned can, in practice, be evaluated from a non-scientificperspective. However, the Appellate Body may well have beenwise not to prioritise the notion of "science" or the "scientific."The kinds of factors that related to a "scientific" assessment ofrisk will evolve as science evolves and also cannot be consideredin abstraction apart from the kind of risk at issue the kind ofpublic policy decision to which the risk assessment is directed.

D. Economic Factors Can be Taken Into Account When Assessing theRisk and Determining the Appropriate Level of Protection

(Article 5.3 of the SPS)

This Article has not been interpreted so far.

E. When Stating Their Objective, WTO Members Must Seek toMinimize Negative Trade Effects (Article 5.4 of the SPS)

None of the Appellate Body reports contain in their ratiodecidendi reference to Article 5.4 of the SPS. However, an ex-plicit reference to this Article is found in the Hormones PanelReport, which in pertinent part reads:

Guided by the wording of Article 5.4, in particular the words"should" (not "shall") and "objective," we consider that thisprovision of the SPS Agreement does not impose an obliga-tion. However, this objective of minimizing trade effects hasnonetheless to be taken into account in the interpretation ofother provisions of the SPS Agreement.39

F. WTO Adjudicating Bodies Will Essentially Review the Means andNot the End (Article 5.6 SPS)

Article 5.6 of the SPS is closely related to Article 5.4 of theSPS. The latter refers to the objective sought by WTO Members,whereas the former addresses the means applied in order to

39. European Communities-Measures Concerning Meat and Meat Products (Hormones),

Complaint by the United States, Report of the Panel, WT/DS26/R/USA (Aug. 18,1997).

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reach the stated objective. As mentioned above, WTO adjudicat-ing bodies will not question the level of the objective sought; allthey can do is examine whether the means used are the leastrestrictive means that a WTO Member could use to reach its ob-jective.

The logical link between means and ends prejudges thestandard of review to be applied by WTO adjudicating bodies: Ifthe goal is to reduce risk to zero, any precaution that makessome additional marginal contribution to bringing the riskcloser to zero will, in principle, be necessary. Hence, adjudicat-ing bodies will have less leeway to examine whether the meansused are indeed the least restrictive option than in a case wherethe objective sought is not as inflexible as a zero risk-policy. Allthese issues have already been explored in WTO case-law.

With respect to the first, the Salmon Appellate Body decisionholds that:

The determination of the appropriate level of protection, anotion defined in paragraph 5 of Annex A, as "the level ofprotection deemed appropriate by the Member establishing asanitary... measure" is a prerogative of the Member and notof the panel or of the Appellate Body .... The "appropriatelevel of protection" established by a Member and the "SPSmeasure" have to be clearly distinguished. They are not oneand the same thing. The first is an objective, the second is aninstrument chosen to attain or implement that objective.4"

The closely related situation where a WTO member has en-acted an SPS measure but has not clearly identified the appro-priate level of protection sought, was addressed in the same re-port which relevantly reads:

[W]e believe that in cases where a Member does not deter-mine its appropriate level of protection, or does so with insuf-ficient precision, the appropriate level of protection may beestablished by panels on the basis of the level of protectionreflected in the SPS measure actually applied. Otherwise, aMember's failure to comply with the implicit obligation to de-termine its appropriate level of protection-with sufficientprecision-would allow it to escape from its obligations underthis Agreement and, in particular, its obligations under Arti-

40. Australia-Measures Affecting Importation of Salmon, Report of the AppellateBody, WT/DS18/AB/R (Oct. 20, 1998).

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338 FORDHAMINTERNZATIONALLAWJOURNAL [Vol. 24:317

cles 5.5 and 5.6.4 '

Second, there is the issue of applying the appropriate testwhen reviewing the means used to reach the sought objective.Again, the Salmon Appellate Body report contains a relevant pas-sage: "What is required under Article 5.6 is an examination ofwhether possible alternative SPS measures meet the appropriatelevel of protection as determined by the Member concerned."4 2

And later, upholding the Panel's findings in this respect theAppellate Body provides the test to be used in order to examinewhether a means is indeed the least restrictive means to reachthe ends sought:

The three elements of this test under Article 5.6 are thatthere is an SPS measure which: (1) is reasonably availabletaking into account technical and economic feasibility; (2)achieves the Member's appropriate level of sanitary orphytosanitary protection; and (3) is significantly less restric-tive to trade than the SPS measure contested. These threeelements are cumulative in the sense that, to establish incon-sistency with Article 5.6, all of them have to be met. If any ofthese elements are not proven, the measure in dispute wouldbe consistent with Article 5.6. Thus, if there is no alternativemeasure available, taking into account technical and eco-nomic feasibility, or if the alternative measure does notachieve the Member's appropriate level of sanitary orphytosanitary protection, or if it is not significantly less trade-restrictive, the measure in dispute would be consistent withArticle 5.6.

In subsequent case-law, the Appellate Body confirmed this find-ing.

44

During the Panel proceedings on Measures Affecting Agricul-tural Products/Varietals ("Varietals Panel Report"), the UnitedStates advanced the argument that Japan could reach its statedobjective by using another less restrictive means. The Panel ex-amined and rejected the U.S. argument, and the Appellate Body

41. Id. § 207.

42. Id. § 204.43. Id. § 194 (emphasis added).

44. See Japan-Measures Affecting Agricultural Products, Report of the AppellateBody, WT/DS76/AB/R (Feb. 22 1999).

45. See Japan-Measures Affecting Agricultural Products, Panel Report, WT/DS76/R(Oct. 27, 1998).

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upheld the result.4 6

It is clear that if presented with evidence by a party to thedispute that a means chosen by a WTO Member to reach ahealth objective is not the least restrictive one, WTO adjudicat-ing bodies will have to entertain the argument and decide ac-cordingly. But in case no argument is presented, or in case thepresented argument is not convincing, can WTO adjudicatingbodies still address questions to the parties in order to make uptheir mind on the degree of restrictiveness of a particular mea-sure?

The WTO case-law provides some answers in this respect.We treat them though when we address the burden of proof is-sue.

G. When Adopting National Standards, WTO Members Must beConsistent (Article 5.5 of the SPS)

The Hormones Appellate Body acknowledges that "the objec-tive of Article 5.5 is formulated as the 'achieving [of] consistencyin the application of the concept of appropriate level of sanitaryor phytosanitary protection."' 4 7

This however should not be equated to a declaration in fa-vour of always consistent SPS policies over time. The same re-port a few lines later explains:

[W]e agree with the Panel's view that the statement of thatgoal does not establish a legal obligation of consistency of ap-propriate levels of protection. We think, too, that the goal setis not absolute or perfect consistency, since governments es-tablish their appropriate levels of protection frequently on anad hoc basis and over time, as different risks present them-selves at different times. It is only arbitrary or unjustifiableinconsistencies that are to be avoided.48

According to the same report, three elements must be cu-mulatively demonstrated for a violation of Article 5.5 SPS to ex-ist:

The first element is that the Member imposing the measure

46. See Japan-Measures Affecting Agricultural Products, Report of the AppellateBody, WT/DS76/AB/R (Feb. 22, 1999).


48. Id.

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complained of has adopted its own appropriate levels of sani-tary protection against risks to human life or health in severaldifferent situations. The second element to be shown is thatthose levels of protection exhibit arbitrary or unjustifiable differ-ences ('distinctions' in the language of Article 5.5) in theirtreatment of different situations. The last element requiresthat the arbitrary or unjustifiable differences result in discrim-ination or a disguised restriction of international trade. Weunderstand the last element to be referring to the measureembodying or implementing a particular level of protectionas resulting, in its application, in discrimination or in a dis-guised restriction on international trade... We consider theabove three elements of Article 5.5 to be cumulative in na-ture; all of them must be demonstrated to be present if viola-tion of Article 5.5 is to be found. In particular, both the sec-ond and third elements must be found.4 9

According to the Hormones Appellate Body report, despitethe fact that the European Community prohibited the use ofsome hormones in beef production, it authorised others for pigproduction. This was held compatible with Article 5.5 of theSPS, even though this difference of treatment was found to bearbitrary or unjustifiable. The fact of the matter was that, in theAppellate Body's view, the third element of its three-prong testwas not met. The motivation of the Appellate Body is found in§ 245 of the Report:

We do not attribute the same importance as the Panel to thesupposed multiple objectives of the European Communitiesin enacting the EC Directives that set forth the EC measuresat issue. The documentation that preceded or accompaniedthe enactment of the prohibition of the use of hormones forgrowth promotion and that formed part of the record of thePanel makes clear the depth and extent of the anxieties ex-periencing within the European Communities concerningthe results of the general scientific studies (showing the carci-nogenicity of hormones), the dangers of abuse (highlightedby scandals relating to black-marketing and smuggling of pro-hibited veterinary drugs in the European Communities) ofhormones and other substances used for growth promotionand the intense concern of consumers within the EuropeanCommunities over the quality and drug-free character of the

49. Id. §§ 214-15.

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meat available in its internal market.50

The Salmon Appellate Body Report applies the same three-prong test when it examines the compatibility of an Australianmeasure with Article 5.5 of the SPS. 51 It further confirms thefinding of the Hormones Appellate Body Report that differencesin level of protection are a "warning signal" that the implement-ing measure in its application might be a discriminatory mea-sure. 51 It thus confirms that different levels of protection as suchare not enough to satisfy the third element of the three-prongtest. To this effect, they are a necessary, but not a sufficient, con-dition.

The Salmon Appellate Body then took note of the fact thatthe Panel had identified two more warning signals 53 and threeadditional factors.5 4

The Appellate Body agreed with Australia that the first addi-tional factor was a mere restatement of the first warning signaland hence should not be taken into account.5 5 It accepts theremaining part of the Panel's analysis and concludes as follows:

We have only reversed the Panel's finding on the first "addi-tional factor." We consider, however, that this reversal doesnot affect the validity of the Panel's conclusion in paragraph8.159 of its Report, that the "warning signals" and "other fac-tors," considered cumulatively, lead to the conclusion thatthe distinctions in the level of protection imposed by Austra-lia result in a disguised restriction on international trade.56

At first glance, a discrepancy appears to exist between thetwo reports although the same standard was applied. There aretwo distinguishing factors between the two cases, however, that

50. Id. § 245.51. See Australia-Measures Affecting Importation of Salmon, Report of the Appellate

Body, 1v/DS18/AB/R (Oct. 20, 1998).52. See Eurogpean Communities-Measures Concerning Meat and Meat Products (Hor-

mones), Report of the Appellate Body, WT/DS26/AB/R (Jan. 16, 1998).53. See Australia-Measures Affecting Importation of Salmon, Report of the Appellate

Body, WT/DS18/AB/R (Oct. 20, 1998) (citing substantial difference in levels of protec-tion and inconsistency of SPS measure at hand with Article 5.1 SPS).

54. Id. §§ 167-74 (citing discrimination between salmon and herring used as bait,substantial but unexplained change in conclusion between two Reports recommendingsaid SPS measures, and the absence of controls on internal movement of salmon prod-ucts within Australia).

55. Id. § 169.56. Id. § 177.

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probably explain the difference in the outcome: First, § 8.32 ofthe Salmon Panel Report states that "the protection of humanlife or health is not at issue in this dispute." Second, the anxie-ties of consumers mentioned in the Hormones Appellate Body re-port were reflected in the EC Directive (in its preamble) but notat all in Australian SPS. Indeed this could hardly be the casesince, as Australia admitted, human life or health was not an is-sue. It appears hence, that the Appellate Body is leaning to-wards a more deferential standard when human life or health isat stake.57

H. National Standards Can be Adopted Even in Absence of ScientificEvidence (Article 5.7 of the SPS)

Article 5.7 of the SPS reflects the "precautionary" principle,which allows WTO Members to take SPS measures even in ab-sence of scientific evidence. Absence of scientific evidence is nottantamount to a statement that WTO Members are completelyunconstrained when enacting SPS measures under Article 5.7 ofthe SPS. The Varietals Appellate Body Report explains that:

[A] Member may provisionally adopt an SPS measure if thismeasure is: (1) imposed in respect of a situation where "rele-vant scientific information is insufficient"; and (2) adopted"on the basis of available pertinent information." Pursuant tothe second sentence of Article 5.7, such a provisional mea-sure may not be maintained unless the Member whichadopted the measure: (1) "seek[s] to obtain the additionalinformation necessary for a more objective assessment of risk"and (2) "review the ... measure accordingly within a reasona-ble period of time." These four requirements are clearly cu-mulative in nature and are equally important for the purposeof determining consistency with this provision. Whenever oneof these four conditions is not met, the measure at issue isinconsistent with Article 5.7.5s

Since the Panel did not examine the two elements appear-ing in the first sentence of Article 5.7 of the SPS and based itsconclusions only on the elements appearing in the second sen-

57. See generally Robert Howse, Democracy, Science and Free Trade: Risk Regulation onTrial at the WJ'O, 98 MICH. L. REV. 2329 (2000) (forthcoming).

58. Japan-Measures Affecting Agricultural Products, Report of the Appellate Body,WT/DS76/AB/R (Feb. 22, 1999).

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tence, the Appellate Body did not have the opportunity to inter-pret the first sentence.

With respect to the elements appearing in the second sen-tence, the Appellate Body observed:

Article 5.7 states that the additional information is to besought in order to allow the Member to conduct "a more ob-jective assessment of risk." Therefore, the information soughtmust be germane to conducting such a risk assessment, i.e.,the evaluation of the likelihood of entry, establishment orspread of, in casu, a pest, according to the SPS measureswhich might be applied. 59

And later:

[W]hat constitutes a "reasonable period of time" has to beestablished on a case-by-case basis and depends on the spe-cific circumstances of each case, including the difficulty of ob-taining the additional information necessary for the reviewand the characteristics of the provisional SPS measure. In thepresent case, the Panel found that collecting the necessaryadditional information would be relatively easy. Although theobligation "to review" the varietal testing requirement hasonly been in existence since 1 January 1995, we agree with thePanel that Japan has not reviewed its varietal testing require-ment "within a reasonable period of time".60

What emerges from case-law, however, is that the additionalinformation must be pertinent and that in case it is relativelyeasy for a WTO Member to collect the additional necessary in-formation, such collection must have taken place within fouryears (since the Appellate Body Report was issued on February22, 1999).

We are still in the dark, however, as to the interpretation ofthe term "available pertinent information" as it appears in thefirst sentence of Article 5.7 of the SPS. This term is perhaps thecornerstone of the whole Article: Since it is by definition lessauthoritative than scientific evidence, we need to know howmuch less is necessary for the "precautionary" principle to beinvoked in the first place.

59. Id. § 92.60. Id. § 93 (emphasis added).

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344 FORDHAMINTERNATIONAL LAWJOURNAL [Vol.24:317

I. To Prove SPS Consistency: Allocation of Burden of Proof to theParties and the Extent of Control by WTO

Adjudicating Bodies

The WTO (like most public international law bodies) con-tains a de-centralized system of enforcement. This means,among other things, that, in principle, parties to a dispute willcarry the burden of proof for their arguments. On the otherhand, WTO adjudicating bodies administer the process and areobliged, under Article 11 of the DSU, to conduct an objectiveassessment of the dispute before them. An issue intimately con-nected with the allocation of burden of proof is the questionwhether WTO adjudicating bodies can move away from claimspresented to them by the parties to a dispute in order to honourtheir commitment to provide an objective assessment. In otherwords the question arises as to whether WTO adjudicating bod-ies have to provide an objective assessment within what has beensubmitted by the parties to the dispute or, conversely, whether inorder to provide an objective assessment they can move to argu-ments and claims not submitted by the parties?

The role of panels in seeking expert evidence is laid out in arudimentary form in Article 13 of the DSU and Article 11.2 ofthe SPS, which essentially enable WTO adjudicating bodies tolook for outside expertise in order to decide SPS-related cases.However, none of the texts mentioned makes it clear whethersuch expertise should be confined to the claims and argumentsas presented by parties to the dispute or whether it can extend toissues not covered by the parties.

Hence, there is an intimate relationship between allocationof the burden of proof and the extent of control by WTO adjudi-cating bodies. We take each issue in turn.

The Hormones Appellate Body report establishes the rule tobe followed when allocating the burden of proof:

The initial burden lies on the complaining party, which mustestablish a prima facie case of inconsistency with a particularprovision of the SPS Agreement on the part of the defendingparty, or more precisely, of its SPS measure or measure com-plained about. When the primafacie case is made, the burdenof proof moves to the defending party, which must in turn

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counter or refute the claimed inconsistency. 61

Hence, it is clear that there is nothing like an ex ante controlof consistency of SPS measures. Such measures are presumed tobe consistent with the WTO unless challenged (and proven to beinconsistent) before a WTO adjudicating body.

The issue presented itself once again in the context of theVarietals litigation. This time, however, with a slight "twist" thatactually bridges the gap between burden of proof and extent ofcontrol by WTO adjudicating bodies, the United States claimedthat Japan did not use the least restrictive option to reach itsobjective.62 According to the U.S. argument, Japan should haveconducted a "testing by product" in order to ensure that its regu-latory objective be met. The Panel sought advice from experts tosee if Japan indeed had not chosen the least restrictive option. Itdid so, however, not with respect to "testing by product," as theUnited States had argued, but with respect to "sorption levels"-another method used to reach Japan's revealed preference,which had not been argued by the United States. Hence, thequestion arose whether the Panel had exceeded the limits of itspower by seeking expertise to establish that another (poten-tially) less restrictive method, not argued by the complainingparty, could have helped Japan reach its objective. The Appel-late Body dealt with the issue in the following manner: "[w]enote that the Panel explicitly stated that the United States, ascomplaining party, did not specifically argue that the 'determina-tion of sorption levels' met any of the three elements under Arti-cle 5.6."63 And later:

Article 13 of the DSU allows a panel to seek information fromany relevant source and to consult individual experts or ex-pert bodies to obtain their opinion on certain aspects of thematter before it. In our Report ... we noted the "compre-hensive nature" of this authority.., to enable a panel to dis-charge its duty imposed by Article 11 of the DSU.....6

And then:


62. See Japan-Measures Affecting Agricultural Products, Panel Report, WT/DS76/R(Oct. 27, 1998).

63. Japan-Measures Affecting Agricultural Products, Report of the Appellate Body,WT/DS76/AB/R (Feb. 22, 1999)

64. Id. § 127.

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[W] e note that the present dispute is a dispute under the SPSAgreement. Article 11.2 of the SPS Agreement explicitly instructspanels in disputes under this Agreement involving scientificand technical issues to "seek advice from experts. '"65

And finally:

Article 13 of the DSU and Article 11.2 of the SPS Agreementsuggest that panels have a significant investigative authority.However, this authority cannot be used by a panel to rule infavour of a complaining party which has not established aprimafacie case of inconsistency based on specific legal claimsasserted by it. A panel is entitled to seek information andadvice from experts and from any other relevant source itchooses, pursuant to Article 13 of the DSU and, in an SPScase, Article 11.2 of the SPS Agreement, to help it to under-stand and evaluate the evidence submitted and the argu-ments made by the parties, but not to make the case for thecomplaining party.66

In a nutshell: The Panel at hand could have sought exper-tise to ensure that the U.S. argument with respect to "testing byproduct" was indeed correct but could not have done so withrespect to "sorption levels" since the complaining party-theUnited States-did not make a specific argument to this effect.This means that panels have unlimited discretion to seek outsideexpertise in order to determine whether a prima facie case hasbeen made. This point was further underlined in the India-Quantitative Restrictions case where the Appellate Body dealt withthe question whether the Panel erred in seeking IMF (Interna-tional Monetary Fund) expertise when examining whether thecomplaining party had indeed made a prima facie case. There,the Appellate Body held:

We do not interpret the above statement as requiring thepanel to conclude that a prima facie case is made before itconsiders the views of the IMF or any other experts that itconsults. Such consideration may be useful in order to deter-mine whether a prima facie has been made.67

Thus, a party challenging an SPS measure carries the bur-den of proof to show that the measure at hand is inconsistent

65. Id. § 128.66. Id. § 129.67. See India-Quantitative Restrictions on Imports of Agricultural, Textile and Industrial

Products, Report of the Appellate Body, WT/DS90/AB/R (Apr. 6, 1999).

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with the treaty. WTO adjudicating bodies can seek expertise topersuade themselves about the well-foundedness of the argu-ments presented by the parties to the dispute but cannot moveto arguments not presented by the parties. That is, to use thecited Varietals litigation as example, VWTO adjudicating bodiescan seek expertise to examine the well-foundedness of the U.S.argument with respect to "testing by product." If they concludethat the U.S. argument is not correct, they cannot move on toexamine whether another method (the 'sorption levels') is in-deed less restrictive than the one chosen by Japan, even if theyknow that this is the case.

J. The Role of the Expert Witness in the Quest for the Truth

Article 13 of the DSU and Article 11.2 of the SPS allowWTO adjudicating bodies to select experts in consultation withthe parties to the dispute. In the context of SPS, seeking outsideexpertise is a routine experience. This is so because of the issuesinvolved: panelists are rarely accustomed to addressing scientificissues.

In the Hormones litigation, the panel first asked parties tothe dispute to name one expert each. It then named two experts(from a list prepared by the Codex Commission and the Interna-tional Agency for Research on Cancer) and one additional ex-pert in the area of carcinogenic effects of hormones.6" The Eu-ropean Community appealed the fact that one of the experts wasnational of a party or third party and had links with the pharma-ceutical industry. The Appellate Body, distinguishing the selec-tion of expert witnesses in the context of SPS from expert reviewgroups (Appendix 4 of the DSU), dismissed the EC argumentand held that: "[o] nce the panel has decided to request theopinion of individual scientific experts, there is no legal obstacleto the panel drawing up, in consultation with the parties to thedispute, ad hoc rules for those particular proceedings."69

In the Salmon case, the Panel chose four experts after con-

68. See European Communities-Measures Concerning Meat and Meat Products (Hor-mones), Complaint by the United States, Report of the Panel, WT/DS26/R/USA (Aug.18, 1997).


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sultations with the Office International des Epizooties ("OIE"). 7 °Finally, in the Varietals dispute, the Panel chose three expertsafter soliciting suggestions from the Secretariat of the Interna-

tional Plant Protection Convention ("IPCC"). 7'

Panels, it appears, will-in consultation with the parties to

the dispute-seek expertise from outside sources following sug-gestions by the organizations mentioned in the SPS Agreement(i.e., OIE, IPCC, Codex). In the Hormones litigation, the partiesto the dispute were given the opportunity to name one expert

each.

In these cases the panels have exhibited some confusionabout the appropriate role of scientific expertise. For exam-ple, in the Salmon case they asked laboratory natural scientistsquestions that related to the costs and benefits of regulatoryalternatives, which bears on matters of politics and econom-ics. It should not be presumed that the relevant expertise inSPS cases will always be that of natural scientists-followingon the remarks of the Appellate Body in Hormones case aboutthe real world in which people live and die, expertise con-cerning the effectiveness and consequences-social and eco-nomic, or even cultural-of particular forms of risk manage-ment and regulatory intervention may be appropriate.

K. A Partial Conclusion

The case law so far on SPS can be reduced to the following

set of propositions:

" WTO Members can enact definitive SPS measures providedthat a risk assessment has taken place.

* WTO Members can also enact provisional SPS measures inthe absence of a risk assessment in the light of availablepertinent information.

" When WTO Members enact definitive SPS measures, theirrisk assessment must be based on scientific evidence.

* For evidence to be considered scientific, some minimumrequirements of procedural or methodological rigour mustbe met.

* SPS measures can be enacted following a risk assessment

70. See Australia-Measures Affecting Importation of Salmon, Report of the AppellateBody, MWT/DS18/AB/R (Oct. 20, 1998).

71. Id.

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based on minority scientific opinions, including views from"non-mainstream" science.

" The scientific evidence does not have to be provided at themoment an SPS measure is enacted; however, it must beprovided when an SPS measure is challenged before aWTO panel.

" The scientific evidence supplied must support the view thatthere is more than a mere abstract or hypothetical possibil-ity of the risk materializing unless the SPS measure at handis enacted; there must be some actual empirical investiga-tion or inquiry into risk.

" WTO Members are free to set the level of risk they are will-ing to undertake at any level they deem appropriate. Whensetting their objective, WTO Members can take into ac-count economic factors as well.

" WTO adjudicating bodies can only examine to what extentthe means chosen to achieve the level sought are the leastrestrictive of trade, and a Member's duty to ensure that itsregulatory process generates least trade-restrictive regulatoryalternatives may be less onerous in cases of obvious seriousthreats to human health than in other kinds of situations.

" In order to examine whether an SPS measure is in accor-dance with the SPS Agreement, WTO adjudicating bodiescan have recourse to expert witnesses. WTO adjudicatingbodies select expert witnesses from the organizations men-tioned in the SPS Agreement in consultation with the par-ties to the dispute. They might as well allow the possibilityto parties to the dispute to name their own experts in addi-tion to those named by the panel. WTO adjudicating bod-ies can decide to take into account unsolicited expertise.

* WTO Members challenging an SPS measure carry the origi-nal burden of proof to show that the relevant provisions ofthe SPS Agreement have not been complied with (inconsis-tency of an SPS measure with any of the above points men-tioned above).

" WTO adjudicating bodies can seek outside expertise to in-form themselves about the well-founded of a party's argu-ment but they have to use such expertise only to informthemselves about the value of arguments as presented bythe parties and not in order to evaluate arguments thathave not been presented by a party.

" When a WTO Member invokes the right to take provisionalmeasures prior to a scientific risk assessment, under Article

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5.7 it must show a rational relationship between the mea-sure it enacts and the risk it wants to avoid.

* When a WTO Member invokes Article 5.7, it must seek tocollect any additional information within a reasonable pe-riod of time, which in one case was deemed to be fouryears.

" In case an SPS measure has found to be inconsistent withthe WTO, it must not be revoked ab initio. Remedies in theSPS context have an ex nunc (prospective) function.

IV. SANITARY AND PHYTOSANITARY RISKS POSED BYRELEASE OF GENETICALLY MODIFIED ORGANISMS

The Manual for Assessing Ecological and Human Health Effectsof Genetically Engineered Organisms ("Manual") summarizes the na-ture and rationale of genetic modification as follows:

Modern molecular methods increasingly are used to produceorganisms that express novel traits. Such methods commonlyare referred to as "genetic engineering" (that is, the isolationof nucleic acid molecules from one organism and their subse-quent introduction into another organism in such a way thatmakes them part of the permanent genetic make-up of therecipient and allows them to be inherited by offspring). Ge-netic engineering techniques currently are used for such di-verse purposes as improvement of agricultural crops and cropyields, enhancement of farmed fish and shellfish broodstocksand their associated yields, production of microbes for bi-oremediation and other specific tasks, and changes in dis-ease-transmission rates by insect vectors. 72

The Manual identifies four broad types of environmental orhuman health risk that can arise from the new organisms thatare the result of genetic modification (the process of geneticmodification is not intrinsically hazardous-the risks arise fromthe characteristics of specific organisms produced from the pro-cess).

The first kind of risk is that which arises from characteristicsthat produce "changes in ecological roles and functions."73 TheManual gives the example of "increased weediness among herbi-

72. Scientists' Working Group on Biosafety, Manual for Assessing Ecological andHuman Health Effects of Genetically Engineered Organisms (1998), at http://www.edmonds-institute.org/manual.htmI [hereinafter Scientists' Working Group].

73. Id.

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cide-tolerant crops. Increased weediness could have potentialnegative impacts on surrounding agricultural fields or on wildvegetation in nearby plant communities."74 The second kind ofrisk is "changes in genetic relationships."75 This occurs when ge-netically modified organisms are released into a setting wherethey cross-breed with other non-modified organisms. Whilecross-breeding of this kind is not intrinsically hazardous, it can insome cases produce contamination of economically importantcrops or even extinction of some species. The third kind of riskis characterized as "indirect effects."76 This kind of risk occurssimply through the interaction over time of novel organisms to aparticular ecosystem, that has not evolved their present charac-teristics in natural relationship with that ecosystem. The riskshere include "changes in population mating structure, alterationof competitive hierarchies, disruption of trophic cascades, andmodification of physical and chemical environments on whichnative species depend."77

The fourth kind of risk, which is the one that has most cap-tured the public imagination, is "changes in allergenicity, toxic-ity, or nutritional composition of foods."7 8 I may know that I amnot allergic to non-modified tomatoes, but how do I know thatgenetically modified versions do not have characteristics that re-lease allergins to which I risk a severe reaction?

Because genetic modification is relatively new as a commer-cial technology, large scale empirical studies of these various ef-fects are lacking. For obvious safety reasons, field trials have gen-erally been small and undertaken with every effort to containany large-scale risk from the trial.79 One problem, identified byindependent scientists, is that much of the relevant informationand technical expertise resides with the industrial interests thathave a stake in marketing GMOs, or with scientists and research-ers with strong industry affiliations. Independent regulatory au-thorities evaluating risks from GMOs, therefore, face importantinformation asymmetries. Nevertheless, there is an increasing

74. Id.

75. Id.76. Id.77. Id.78. Id.79. See ORGANISATION FOR ECONOMIC CO-OPERATION AND DEVELOPMENT, SAFETY

CONSIDERATIONS FOR BIOTECHNOLOGY. SCALE-UP OF CROP PLANTS (1993).

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body of research that is independent of industry, ° although theresults and methodology are often ferociously contested by theindustry and its experts.

V. PITH AND SUBSTANCE OF EUROPEAN UNIONREGULATION OF DELIBERATE RELEASE OF

GENETICALL Y MODIFIED ORGANISMS

The original centerpiece of EU regulation of GMOs is Di-rective 90/219/EEC. This Directive was amended in 1997, pri-marily with a view to introducing compulsory labelling of prod-ucts containing GMOs. There are related, detailed regulationswith respect to use of GMOs in pharmaceuticals, novel foods,feeds, and seeds; but, generally speaking these suppose and sup-plement the general regulatory approach contained in directive90/219/EEC as amended.8" The approach in the Directive is tobase approval of the deliberate release of GMOs or their market-ing in products in the EU, on prior case-by-case assessment ofrisk to human health and the environment. GMOs and GMOproducts are only to be approved if they are determined to be"safe" for the environment and human health, on the basis ofscientific risk assessment. The first step in this process is for theimporter or manufacturer to notify the relevant authority of anEU member state, requesting permission for release or placingon the market. The notifying entity is required to supply a rangeof information in its possession that is needed to allow for anassessment of risk to human health and to the environment. Ifthe member state authority approves the request, the Commis-sion and other member states are to be given an opportunity tofile objections. A decision is then taken at the Community levelby weighted majority voting in the Council. The process of thedecision making at the community level, provision is made forconsultation with the scientific committees of the Commission.Since the entry into force of the original Directive, eighteen re-quests have been approved.8 2 However, since 1998, in response

80. See, e.g., Dr. Charles Benbrook, Who Control and Who Will Benefit from PlantGenomics?, Presented before The 2000 Genome Seminar: Genomic Revolution in theFields: Facing the Needs of the New Millennium, AAAS Annual Meeting, Washington,D.C. (Feb. 19, 2000), at http://www.biotechinfo.net/AAASgen.html.

81. European Commission, Facts on GMOs in EU, MEMO/00/43 (July 13, 2000)(outlining roadmap of these regulatory schemes).

82. Id.

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to increased public concern about GMOs many member stateshave instituted a de facto moratorium on approvals. In somecases, products authorized for placing on the market have beenbanned, based on Article XVI of the original Directive, whichallows member states to take such action "provisionally," wherethey have 'justified reasons" on human health or environmentalgrounds.

It is against this backdrop that the Directive has recentlybeen revised, the outcome of a reconciliation exercise betweenthe Commission and Council and the Parliament. The JointText approved by the Conciliation Committee83 was adopted bythe European Parliament in a legislative resolution of February14, 2001.84

A. International Standards, SPS, and European Regulation of GMOs

Is evolving EU regulation, especially as reflected inamended directive 90/220, "based on" international standards,guidelines, and recommendations, within the meaning of Article3.1 of the SPS? Moreover, does it "conform to" internationalstandards, within the meaning of 3.2? In the case of food safety,which is only one of the regulatory concerns in the case ofGMOs, the relevant international standards are, according toAnnex A of the SPS, those of the Codex Alimentarius Commis-sion, and joint endeavor of the Food and Agriculture Organiza-tion ("FAO") and the World Health Organization ("WHO").

The Codex has established an Ad Hoc IntergovernmentalTask Force on Foods Derived from Biotechnology, which ischarged with the task of developing standards for assessment ofthe safety of foods derived from biotechnology by the year2004.85 In addition, certain issues related to the regulation ofGMOs are under consideration at the Codex Committee onGeneral Principles (including issues related to the precautionaryprinciple and labelling).

From the SPS perspective the issue is how Articles 3.1 and3.2 should be applied when the Codex is explicitly in the process

83. CSL 3664/2000, hereinafter, "Joint Text."84. PE R5 0075/2001.85. SeeWORLD HEALTH ORGANIZATION, REPORT OF THE FIRST SESSION OF THE CODEX

AD Hoc INTERGOVERNMENTAL TASK FORCE ON FOODS DERIVED FROM BIOTECHNOLOGY

(Mar. 14, 2000).

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of developing international standards, but these have not yetbeen promulgated. Pursuant to SPS Annex A.3(d), where foodsafety matters are "not covered" by Codex, reference is to be hadto appropriate standards, guidelines, and recommendations ofother relevant international organizations. Does "not covered"include a situation where the Codex is seized of the matter buthas not yet promulgated standards? We submit that such a situa-tion should indeed come under the meaning of "not covered,"for the alternative would be to ignore other relevant interna-tional standards until Codex has acted, which would be contraryto some of the general objectives of the SPS Agreement, includ-ing the encouragement of the use of harmonized internationalstandards where they exist.86

There are a range of non-Codex standards, guidelines, andrecommendations concerning the regulation of risks from therelease of GMOs, which deal both with food safety- and non-foodsafety related risks of GMOs. Of high relevance is the Statementof the FAO, one of the Codex partners, on biotechnology. Ac-cording to the Statement:

[The] FAO supports a science-based evaluation system thatwould objectively determine the benefits and risks of eachGMO. This calls for a cautious case-by-case approach to ad-dress legitimate concerns for the biosafety of each product orprocess prior to its release. The possible effects on biodivers-ity, the environment and food safety need to be evaluated,and the extent to which the benefits of the product or pro-cess outweigh its risks assessed. The evaluation processshould also take into consideration experience gained by na-tional regulatory authorities in clearing such products. Care-ful monitoring of the post-release effects of these productsand processes is also essential to ensure their continued safetyto human beings, animals and the environment. 87

While these suggestions are perhaps too general to be consid-ered as standards, they are certainly at a minimum, recommen-dations or guidelines.

The Cartagena Protocol on Biosafety, concluded at Montreallast year-to which the European Union member states are sig-

86. See SPS Agreement.87. Food and Agriculture Organization of the United Nations, FAO Statement on

Biotechnology (2000), at http://www.fao.org/biotech/state.htm [hereinafter FAO State-ment].

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natories-facilitates the approach, recommended by the FAO, ofcase-by-case analysis prior to release, by imposing rights and obli-gations with respect to advance notice of proposed cross-bound-ary movement of GMOs and related material."8 The Protocol alsorequires scientifically sound assessment of risk (Article 15), andin an Annex promulgates general principles and guidelines withrespect to the methodology and factors to be taken into accountin risk assessment. Further, the Protocol states that:

Measures based on risk assessment shall be imposed to theextent necessary to prevent adverse effects of the living modi-fied organism on conservation and sustainable use of biologi-cal diversity, taking also into account risk to human health,within the territory, of the Party of import.8 9

Within 270 days of notification, a country of import must pro-vide its decision to the notifier as to whether the import is per-mitted, and if so, under what conditions (Article 10).'o To datesixty-eight states have signed the Protocol; because it is open tosignature by any WTO Member (in fact by any State), the Protocolqualifies as the standards, guidelines, or recommendations of arelevant international organization, within the meaning of SPSAnnex A.

By contrast, although the OECD has promulgated variousguidelines with respect to biotechnology, as an organizationwhose membership is not open to all WTO Members, these pro-nouncements do not qualify as international standards withinthe meaning of the SPS. 1

The main features of EU regulation, as reflected in the re-vised directive, and the novel foods regulation, are based on theapproach now formally reflected in the international standards,namely case-by-case risk assessment prior to release of each indi-vidual GMO.12 Like both the FAO Statement and the CartagenaProtocol on Biosafety, EU regulation requires such risk assessment.

88. See Cartagena Protocol on Biosafety (Feb. 23, 2000, at http.www.jiwlp.com/con-tents/Cartagena-Protocol.htm [hereinafter Cartagena Protocol on Biosafety].

89. Id. art. 16.2.90. Id. art. 10.91. However, to the extent that the parties to an SPS dispute are also OECD mem-

bers, OECD guidelines would still be relevant as sources of treaty interpretation underthe Vienna Convention on the Law of Treaties, May 23, 1969, 115 U.N.T.S. 331 (en-tered into force Jan. 27. 1980) [hereinafter Vienna Convention].

92. Art 4.2, 4.3.

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The amended Directive requires an environmental risk assess-ment ("ERA") to be undertaken by the notifier, which providesthe basis for an assessment report by competent member stateauthorities. While not identical, the kinds of risks and factors tobe taken into account in ERA and in the Assessment Report arequite similar to those set out in the Cartagena Protocol on Biosafety.In several respects, the EU regulation is more favorable to im-ports than the Cartagena Protocol on Biosafety-it specifies ashorter time period for an initial decision of national authoritieson whether release is to be permitted (ninety days). Theamended EU directive specifically bans restrictions or prohibi-tions by member states on the placing on the market of GMOsthat comply with the requirements of the directive (Article 22);in effect then restrictions on market access are as a matter of lawlimited to those based on health and environmental risks.

Does the EU regulation "conform to" international stan-dards within the meaning of 3.2 of the SPS Agreement? Themeaning of "conform to" is, according to the Appellate Body (asnoted in the first part of this Essay), stricter than "based on."Article 3.2 must be read in conjunction with Article 3.3-thusthe real issue is whether in all relevant respects the EU regula-tion does not attempt to achieve a higher level of protection thanthat which would be achieved by international standards.

There are several relevant respects in which EU regulationcould be considered to aim at a higher level of protection.While the FAO Statement appears to impose upon risk assess-ment a kind of cost benefit analysis, where if the prospectivebenefits of a GMO outweigh the risks identified in risk assess-ment the GMO might well be released, the approach of the EUdirective is apparently more cautious. The the amended direc-tive provides that "Member States shall ensure that all appropri-ate measures are taken to avoid adverse effects on human healthand the environment which might arise from the deliberate re-lease or placing on the market of GMOs."93 The principles forEnvironmental Risk Assessment in Annex II and the Guidelinesfor Assessment Reports of member state authorities in Annex VIfocus exclusively on risks. Potential benefits of release or placingon the market appear to play no part in the approval process.However, the FAO Statement does not suggest that in all cases

93. Art. 4.1.

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release is appropriate if benefits outweigh CoSts.9 4 It does, never-

theless, call for an assessment of benefits in relation to costs.The Cartagena Protocol on Biosafety calls for the taking of mea-

sures that are "necessary" to protect biodiversity and humanhealth as well. Does the use of the expression "appropriate" inthe EU Directive indicate a higher standard of protection thanthe necessity test in the Cartagena Protocol on Biosafety? The an-swer is not ascertainable in the abstract, but depends upon theactual practice of EU member states in implementing the Direc-tive, which so far, under the 1990 Directive, including asamended in 1997, has varied considerably.95 However, theGuidelines for Assessment Reports define the relevant risks tohuman health and the environment from GMOs as "any newrisks that may arise from the release of GMOs as compared to therelease of the corresponding non-modified organism(s)."9 6

Thus, while the amended directive requires that all appropriatemeasures be taken to ensure "safety," the standard for safety is arelative one-relative to the existing levels of safety with respectto corresponding non-modified organisms. By contrast, the stan-dard in the Cartagena Protocol on Biosafety is an absolute one, re-quiring that all necessary measures be taken to prevent harm tothe environment from GMOs, apparently regardless of whethera signatory is taking comparable precautions against environ-mental harm or human health impacts from non-GMO productsand materials.97 In this sense, the level of protection in the Car-tagena Protocol on Biosafety may actually be higher, rather thanlower, than that provided for in the amended Directive. How-ever, it is to be noted that Article 32 of the amended directiveenvisages that the Cartagena Protocol shall be fully implementedin EU law, and that where necessary there be further amend-ments to the directive in order to accomplish this.

Secondly, while the amended directive contains even morecomplex and precise provisions on labelling and traceabilitythan did the 1997 amendment to the 1990 GMOs directive,neither the FAO Statement nor the Cartagena Protocol on Biosafety

94. See FAO Statement, supra note 87.95. See Ren6 von Schomberg, An Appraisal of the Working in Practice of Directive 90/

220/EEC on the Deliberate Release of Genetically Modifled Organisms, Jan. 2, 1998, at http://www.europarl.eu.int/stoa/publi/pdf/gmostudy-en.pdf.

96. Annex VI(4) (emphasis added).97. See Cartagena Protocol on Biosafety, supra note 88.

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explicitly requires labelling. However, the FAO Statement de-clares that "[c]areful monitoring of the post release effects ofthese products and processes is also essential to ensure their con-tinued safety human beings, animals and the environment."98Without the ability to identify and trace the presence of GMOsin particular products or processes, monitoring their effectsonce released would be highly impracticable, if possible at all.Hence, labelling and traceability requirements are, in the con-text of GMOs, a necessary implication of the notion of "carefulmonitoring of post release effects," and in this sense conform tothe standards, guidelines, and recommendations in the FAOStatement. Moreover, as is recognized in the provisions in theCartagena Protocol on Biosafety on transboundary shipment ofGMOs, identification may be crucial to risk management andcontrol, preventing inadvertent release of GMOs in contexts orecosystems where they can cause damage. In the case of foodsand food products as well, labelling may be a "necessary" mea-sure for the protection of human health within the meaning ofArticle 16 of the Cartagena Protocol on Biosafety, alerting personswith allergies, or hyper-sensitivity to certain foods that theproperties in a food containing GMOs may be different fromthose in the non-modified version, which are known to such in-dividuals as safe for them.99 This is discussed further below.

Finally, the amended directive, in the guidelines for Assess-ment Reports by member state authorities, provides for "assess-ment of whether the genetic modification has been character-ized sufficiently for the purpose of evaluating any risks to humanhealth and the environment."' ° This raises the possibility thatan assessment report could come to the conclusion that a GMOnot be released on precautionary grounds, i.e., because of notbeing able to characterize the modification sufficiently in orderto evaluate risks to human health and the environment. This isreinforced by references to the Precautionary Principle in anumber of places in the amended directive, and especially in Ar-ticle 4.1, which states that all appropriate measures are to betaken to avoid adverse effects "in accordance with the precau-tionary principle." However, this conforms with the articulation

98. FAO Statement, supra note 87.99. See Gillian Hadfield & David Thomson, An Information-Based Approach to Label-

ling Biotechnology Consumer Products, 21 J. CONSUMER POL'Y 193 (1998).100. Annex VI, para. 3.

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of the Precautionary Principle in the Cartagena Protocol on Bi-osafety, Article 11.8 of which provides:

Lack of scientific certainty due to insufficient relevant scien-tific information and knowledge regarding the extent of po-tential adverse effects of a living modified organism on theconservation and sustainable use of biological diversity in theParty of import, taking also into account risks to humanhealth, shall not prevent that Party from taking a decision, asappropriate with regard to the import of that living modifiedorganisms intended for direct use as food or fee, or forprocessing, in order to avoid or minimize such potential ad-verse effects. 1'

In sum, it is our view that evolving EU regulation as re-flected in the amended directive, and in the novel foods regula-tion, conforms to such international standards, recommenda-tions, and guidelines as now exist, within the meaning of the SPSAgreement. At the same time, since, as noted, internationalstandards are evolving, particularly in Codex Alimentarius, it isfar from an academic exercise to consider, arguendo, if EU regu-lation, as it is evolving, could be sustained under the SPS if it didnot "conform to" international standards, but sought to achievea higher level of protection.

B. Articles 2.2 and 5.1-5.3 of the SPS

To the extent that there are elements of EU regulation thatseek to establish a higher level protection, they do not enjoy thepresumption that they are maintained on the basis of sufficientscientific evidence 0 2 and they must be maintained consistentlywith the various provisions of Article 5.1"3 As recalled, in theVarietals case, the Appellate Body, elaborating on its decision inthe Hormones case, stated that the sufficient evidence standard inArticle 2.2 is met where there is a rational connection betweenscientific evidence on the record and the measures taken. 10 4

However, the Appellate Body also indicated that a case-by-case

101. Cartagena Protocol on Biosafety, supra note 88, at art. 11.8.102. See SPS Agreement art. 2.2.

103. See European Communities-Measures Concerning Meat and Meat Products (Hor-

mones), Report of the Appellate Body, WT/DS26/AB/R (Jan. 16, 1998) (stating inter-pretation by Appellate Body of art. 3.3 of SPS Agreement).

104. See Japan-Measures Affecting Agricultural Products, Report of the AppellateBody, WT/DS76/AB/R (Feb. 22 1999).

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contextual judgement is needed about what kind of underlyingscientific evidence satisfies the requirement of rational connec-tion. In some cases, this would have to include evidence proba-tive of causal relationships.

To recall, Article 5.1 of the SPS requires that measures bebased on an assessment of risk "appropriate in the circum-stances." Articles 5.2 and 5.3 list a variety of factors to be takeninto account in such risk assessments.

The amended directive requires that a member state deter-mination of whether release and marketing of GMOs or GMOproducts is permitted be based on an Environmental Risk Assess-ment. This ERA is to be conducted by the firm requesting thepermission. On the basis of this ERA, the member state authori-ties must prepare an Assessment Report. As already noted, theReport must include, inter alia, "[and] assessment of whether thegenetic modification has been characterized sufficiently for pur-pose of evaluating any risks to human health and environ-ment,"115 and "[iildentification of any new risk to human healthand the environment that may arise from the release of theGMOs in question as compared to the release of the correspond-ing non-modified organisms, based on the environmental riskassessment. ' 6 Where it is concluded that a GMO should not beplaced on the market, reasons must be given in the assessmentreport. While these provisions do not adopt the exact languageof SPS Article 2.2, it is fairly obvious that the amended directiverequires that the decision to prohibit release or marketing ofGMOs be based on reasons grounded in scientific evidence ofrisks to human health and the environment. The only apparentexception is where the competent authority determines thatthere is insufficient scientific evidence to evaluate risk, in whichcase the overall approach of the amended directive would ap-pear to permit a decision against release or marketing on pre-cautionary grounds. In such a case, there would be a violation ofSPS Article 2.2 unless the decision could be justified under SPSArticle 5.7, to which we shall turn later in this article.

With respect to the labelling and traceability requirementsas they exist in the amended directive,0 7 an issue might seem to

105. Annex VI.3.106. I.107. See Art. 19.3(e), Art. 21, Annex IV.

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arise under Article 2.2, since the labelling and traceability re-quirements apply generally, regardless of the results of case-by-case risk assessment. However, these requirements must be un-derstood in light of the inherent limitations of existing tech-niques of risk assessment to achieve high levels of certainty aboutthe health and environmental effects of GMOs.'0 8 The qualityand precision of risk assessment may depend upon increasinginformation about the effects of release of GMOs in the realworld. Regardless of whether a new GMO has passed a risk as-sessment, there is likely to be continuing uncertainty as to itsactual health and ecological effects. Without labelling and trace-ability, identifying genetic modification as a possible cause ofreal world health and ecological effects would be renderedmuch more difficult and costly. It would be contrary to the prin-ciple of effective treaty interpretation to read Article 2.2 of theSPS as raising a bar to measures that are themselves conditionsprecedent to fully adequate scientific assessment of risk, or toproviding Members with a more adequate scientific foundationfor their measures in the future. Moreover, as the AppellateBody emphasized in Hormones, risk assessment-in which it is de-termined whether scientific evidence is sufficient-includes con-sideration of the requirements of controlling risk in the realworld, not just the laboratory. Thus, even if the labeling require-ment is not the outcome of the case-by-case risk assessment re-quired to determine whether more restrictive measures are ap-propriate, it can nevertheless be justified, in terms of a cost-effec-tive response with respect to foods at least. But for labelling, thereal and largely uncontroversial risk that genetically modifiedfoods may contain allergins and toxins not contained in the non-genetically modified versions would be indistinguishable to the"thin-skull" or particularly susceptible consumer.

The substantive threshold of "sufficient" scientific evidencein SPS Article 2.2 is closely related to the procedural require-ments of risk assessment as set out in SPS Articles 5.1-5.3. Theselatter provisions require that SPS measures be based on a scien-tific assessment or risk and specify some of the factors that mustbe taken into account. As discussed in depth in the first part ofthis Essay, in the Salmon case, the Appellate Body held that

108. See Von Schomberg, supra note 95; see also Scientists' Working Group, supranote 72.

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under Article 5, a risk assessment must establish not simply themere possibility of a risk event occurring but rather the likeli-hood or probability of such an event." 9 At the same time, in notrequiring that such assessment of likelihood or probability bequantitative, the AB apparently embraced the view that the SPSAgreement does not establish or impose thresholds for scientificcertainty, determinacy, or margins of error, below which SPSmeasures are not considered to be "based on" scientific risk as-sessment, other than the threshold of "sufficient scientific evi-dence" in Article 2.2. It is in this sense that the precautionaryprinciple is built into Article 5 as a whole-it does not preventregulators from acting in response to possible serious harm evenwhere there are significant elements of uncertainty or indetermi-nacy in the risk assessment.

In the case of GMOs, these elements of uncertainty or inde-terminacy are of several different kinds. One kind of uncer-tainty relates to the extent one can extrapolate results of smallfield trials to larger regions, populations, or ecosystems. Investi-gators have been understandably reluctant to expose largerpopulations of humans or other species to such trials, preciselybecause the extent of adverse effects is not well known yet.'One response might be to conduct computer simulations basedupon existing knowledge of the properties of larger ecosystems.But here too there are inevitable elements of uncertainty or im-precision in predicting effects in actual ecosystems. Anotherkind of uncertainty relates however to the simple failure to de-sign and conduct a particular experiment: "[F]or example, wemay not know how bio-tech crops will affect soil micro-organismssimply because experiments have not been designed to detectsuch effects." It is doubtful whether this kind of uncertainty inrisk assessment could be acceptable under the SPS, since it re-sults from a failure to undertake possible further investigations.However, in the case of prevention of life threatening riskswhere those further investigations are unwarranted from theperspective of costs or would result in delays of a kind that couldresult in irreparable harm, it might be possible to mount ajustifi-cation for regulations on the basis of more uncertain results.

109. See Australia-Measures Affecting Importation of Salmon, Report of the AppellateBody, WT/DS18/AB/R (Oct. 20, 1998).

110. See generally, Von Schomberg, supra note 95.

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The Principles for Environmental Risk Assessment in AnnexII of the amended directive address themselves to the range offactors stated in SPS Articles 5.1-.3.111 Potential adverse effectsof the GMO are to be identified, as well as the magnitude ofsuch effects, and the likelyhood of their occurrence. This is tobe the basis for an estimate of risk to health and the environ-ment, to the extent that the state of the art permits such an esti-mate to be made. The ERA is to be carried out in a scientificallysound and transparent manner. They are moreover broadly con-sistent as already noted with the risk assessment guidelines pre-sent in the Cartagena Protocol on Biosafety and they are reflective aswell of best scientific practice, as codified for instance in theScientists' Work Group on Manual.1 1 2

With respect to the requirement stated in the definition ofrisk assessment in Annex A, paragraph 4 of the SPS, that a riskassessment evaluate the "likelihood" of adverse effects material-izing the Principles in Annex II of the amended directive wouldappear to satisfy the concern of the Appellate Body in Salmonthat evaluation of "likelihood" not merely be a matter of statinga vague or abstract possibility, but consist in an effort to statewith some precision or specificity the incidence of risk.113 Thus,evaluation of the "likelihood of the occurrence of each identi-fied potential adverse effect" is required, taking into account thereal-world conditions of the environment into which the releaseis going to take place.' 14 Similar precision is required with re-spect to estimation of the magnitude of the harmful conse-quences. Moreover, with respect to effects, these must be clearlyclassified in terms of direct or indirect, and immediate ordelayed.

Of particular importance, given the apparent availability ofmore precise and adequate techniques of risk assessment incases like Salmon and Varietals,1 5 is the stipulation in the Princi-ples that "estimation" of risk be made as far as possible, "given

111. See Annexes II, VI.

112. See generally, Scientists' Working Group, supra note 72.

113. See Australia-Measures Affecting Importation of Salmon, Report of the Appellate

Body, WT/DS18/AB/R (Oct. 20, 1998).

114. Common Position Annex II, Part C, para. B.

115. The defendants in both of these cases did not give adequate explanations oftheir failure to employ.

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the state of the art."'"16

C. Articles 5.4 and 5.6 of the SPS: Least-Restrictiveness of Trade

Article 5.4 of the SPS states that Members should take intoaccount the "objective of minimizing negative trade effects"when determining the appropriate level of protection. In turn,Article 5.6 requires that Members ensure that measures adoptedare the least trade restrictive necessary to achieve the appropri-ate level of protection, "taking into account technical and eco-nomic feasibility."

As the Appellate Body has emphasized particularly in theSalmon case, the application of Article 5.6 requires a characteri-zation of a Member's appropriate level of protection. As we havealready suggested, the level of protection implicit in theamended directive is that of "safety," relative to the correspond-ing non-genetically modified product or process and as deter-mined by case-by-case risk assessment. In other words, the EUjudges unacceptable any margin of risk beyond that posed bynon-genetically modified equivalents. To what extent does thislevel of protection reflect the obligation to "take into account"the objective of minimizing negative trade effects in SPS Article5.4? In this regard it should be noted that, in selecting as aneffective baseline the degree of safety already required of non-modified organisms, the EU has chosen a level of protectionconsistent with the established expectations of its trading part-ners as to the conditions of market access for their products andprocesses to the common market, insofar as human health andenvironmental safety are concerned.

With respect to the least trade restrictive requirement inSPS Article 5.6, there are a number of features in amended di-rective that have the effect of limiting the potential trade restric-tiveness of member states' measures on GMOs. First, as notedabove, 22 provides that once a GMO or GMO-containing prod-uct has been approved as safe on the basis of risk assessment, nofurther restrictions or prohibitions on market access shall be im-posed by member states' authorities (except where there is newinformation suggesting imminent threat to the environment orhuman health). Secondly, to the extent that the EU's appropri-ate level of protection can be satisfied by less onerous or more

116. Annex II, C.2.4. para. 5.

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expeditious approval procedures, provision for these is made inthe amended directive.117 Thirdly, the amended directive con-templates the possibility of conditional consent to placing ofGMOs on the market, i.e., that through appropriate methods ofrisk containment or risk management, the appropriate level ofsafety can be maintained without the obviously more trade-re-strictive response of a denial of permission to market the GMOproduct or process."' Finally, in order that labelling require-ments not become an unnecessary impediment to market access,in cases where ascertaining whether there are "adventitious"traces of authorized GMOs in a particular product is technicallyunfeasible, the amended directive allows member states to estab-lish a minimum threshold, below which labelling is not re-quired. 1 9 Moreover, the time frames provided in the amendeddirective for decisions on individual GMOs appear close to theminimum that could reasonably be required to undertake thenecessary scientific verification and for regulatory decision-mak-ing consistent with meaningful consultation of scientific expertsand the public.

The amended directive also reflects the recognition that sci-entific knowledge of GMOs is in a state of transition, as is theindustry itself, and thus provides for review of experience withthe directive in 2003. This review is to consider, inter alia,whether sufficient experience has occurred with "differentiated"i.e., streamlined procedures, to expand the scope for permittingthe release or placing on the market of GMOS without prior in-dividualized risk assessment. 120 Thus, at a point at which scien-tific knowledge and regulatory experience is such that a less re-strictive approach is appropriate, it is foreseen that such an ap-proach may be adopted.

D. SPS Article 5.5: "Arbitrary or Unjustifiable Distinctions"

Article 5.5 of the SPS requires that WTO Members avoidarbitrary or unjustifiable distinctions in the levels of protectionthey consider appropriate in different situations, if such distinc-tions result in discrimination or a disguised restriction on inter-

117. See id. art. 7.118. See id. art. 18, 3.c.119. See id. art. 21.2.120. See id. art. 31.7.c.

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national trade. As already noted, the Common Position is basedon a level of protection that can be characterized as no lesssafety than that attributable to corresponding non-modified or-ganisms. However, it might be argued that, if one reads the EU'slevel of protection back from the kind of measures it is propos-ing, which could be the approach of the Appellate Body giventhat the level of protection is not explicitly stated as such in anyprovision of the amended directive, in fact the level is considera-bly higher than that for non-modified organisms. In general,with respect to the latter, no prior case-by-case risk assessment isrequired before the product is put on the market. Among thearguments of industry interests that proclaim GMOs to be "safe"is that genetic engineering merely imitates-and directs tohuman needs-genetic modification and adaptation of the kindthat occurs in nature itself, and thus does not impose risks thatare different in kind from those posed by cross-breeding and ge-netic modification of organisms in nature.

In fact, there are very important distinctive characteristics ofGMOS that make the analogy to natural processes very mislead-ing when seen from the perspective of risk assessment and man-agement. These are summarized by Regal:

[R]DNA differs in at least four fundamental ways from bothordinary sexual reproduction and conventional breeding: 1)Adaptive traits can be leap-frogged over vast phylogenetic dis-tances to form radically new combinations of competitive fea-tures; 2) sexual reproduction and traditional breeding arelargely limited to exchanges of alleles (which are variants ofgenes, and exchanges typically demand substitutions andadaptive trade offs and compromises, but with rDNA this classof exchange-based trade-offs can be circumvented. 3) Sexualreproduction and traditional breeding cannot normallyreprogram the large fraction of genomes that are functionallyhomozygous. But rDNA holds the potential to reprogramfundamentally important genetic programs that are normallyprotected against change. 4) Transgenes often have unusualgenetic side effects, apparently when a host organism's edit-ing and buffering systems do not recognize them and cannotcorrect or control them properly.1 21

What do these differences mean in terms of the challenges

121. Philip Regal, A Brief History of Biotechnology Risk Debates and Policies in the UnitedStates (1999), at http://www.edmonds-institute.org/regal.html.

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for risk regulation? Simply put, genetic engineering removes oralters many restraints or controls that limit variation in nature,resulting in a vast potential expansion of variants and the speedat which they occur. Reliance on long-acquired general knowl-edge of the properties of non-genetically modified foods mightbe reasonable given the EU's level of protection, whereas a re-quirement that specific investigation be undertaken with respectto GMOs may also be reasonable, given the same level of protec-tion, in light of the greater degree of uncertainty and relativespeed at which new organisms with unknown risk properties rel-ative to specific ecosystems can be created. Finally, we note that,in the Hormones case, the Appellate Body held that there mightbe a range of acceptable reasons why regulation of risks inherentin nature in the absence of any human intervention might re-flect a lower level of protection than that of risks produced orexacerbated by human artifice. 22

VI. SPS AND THE PRECAUTIONARY PRINCIPLE

This brings us to Article 5.7 of SPS and its relationship tothe precautionary principle or approach. Article 5.7 allows forprovisional adoption of sanitary and phytosanitary measureswhere "scientific evidence is insufficient," provided the Memberseeks more adequate information and reviews the measures ac-cordingly within a reasonable period of time. One obviousmeaning of Article 5.7 is that it allows for provisional measureswhere the state of scientific knowledge is such that the kind ofrisk assessment set out in the preceding paragraphs of Article 5is not possible. While the overall EU scheme for regulation ofGMOs in the amended directive is based on the precautionaryprinciple, in the sense that it requires prior approval on a case-by-case basis, rather than assuming the safety of GMOs untilproven otherwise, it is not precautionary in the sense evoked byArticle 5.7.12' As we have already noted, the amended directive

122. See European Communities-Measures Concerning Meat and Meat Products (Hor-

mones), Report of the Appellate Body, WT/DS26/AB/R (jan. 16, 1998).123. We suppose that some might argue that the requirement of case-by-case risk

assessment is itself an SPS measure that must be maintained on the basis of sufficientscientific evidence, or'based on a scientific assessment of risk within the meaning ofArticles 5.1-5.3. But such an interpretation is infine casuistical. It would put, at least inthe GMO context, the EU and other Members in a "Catch-22" situation. In order tomeet the requirements of the SPS they must do risk assessment, but they cannot impose

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specifies the elements of a risk assessment based upon scientificmethodology. And in this it is consistent with the Cartagena Pro-tocol on Biosafety as well as the particulars of SPS Articles 5.2-5.3.Yet, as the Appellate Body suggested in Hormones, Article 5.7does not exhaust the relevance of the precautionary principle orthe precautionary approach to the interpretation of the SPSAgreement. Caution or pre-caution is relevant to the way thatpoliticians and regulators respond to elements of uncertainty, in-determinacy, and margins of error in risk assessment, especiallywhere if harms do materialize the consequences will be grave orcatastrophic. 1

24

As already noted, the Guidelines for Assessment Reports inthe amended directive require that the member state authorityinclude in its report an assessment of "whether the genetic modi-fication has been characterized sufficiently for the purpose ofevaluating any risks to human health and the environment."'' 25

While the amended directive does not specify what decision con-cerning permission to place on the market is appropriate, whereit is determined that the genetic modification has not been char-acterized sufficiently, clearly the possibility in such a situation thatpermission would be denied is contemplated. This would pre-cisely be the kind of case where the EU would be required toinvoke Article 5.7 to justify a denial of permission to place GMOson the market.

With respect to the conditions in Article 5.7, the amendeddirective does not contain any provision for reconsideration of adecision to deny permission based on new information. Thiscontrasts with the situation where permission has been granted,in which case there is a formal process provided for reconsidera-tion of the permission in light of new information about risks.1 26

This being said one must interpret the requirements of SPS Arti-cle 5.7 "to seek to obtain additional information" and to review

risk assessment itself as a precondition for a decision about their measures, unless theyalready have a scientific basis for doing so. However, once the properties of a standardset of GMOs are better known, as discussed above, imposing this kind of requirementcould be more trade restrictive than necessary to achieve the EU's appropriate level ofprotection; but the common position provides for consideration of streamlined proce-dures as better information about GMOs evolves.

124. See Katherine Barrett, Applying the Precautionary Principle to Agricultural Biotech-nology, in SCIENCE AND ENVIRONMENTAL HEALTH NETWORK (2000).

125. Annex VI.3.126. See id. art. 20.

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the measure within a reasonable period of time, in light of theoverall structure of the amended directive. Since informationabout the characteristics of GMOs is in the first instance in thehands of those who produce them, the amended directive clearlyplaces the onus providing adequate information for an assessmentbased upon scientific evaluation of risks upon the party seekingpermission. If, in a particular case the information is inade-quate, the precautionary action by a member state authority maybe taken. Nothing in the amended directive prevents a notifierwho has been denied permission, from reapplying for permis-sion, while providing more adequate information for purposesof evaluating risk. By not limiting in any way, or prejudicingsuch re-applications, the EU is in effect inviting, or "seeking" ad-ditional information. With respect to the SPS requirement ofreview of measures taken under Article 5.7, there is nothing inthe structure and language of 5.7 that suggests that a WTOMember must undertake a review, in the absence of interest onthe part of the market actor with an interest in the measure be-ing reconsidered. In effect-as already suggested-a notifiercan trigger review of a decision, not to permit release or placingon the market of GMOs, simply by submitting a new notificationat any time, which the competent member state authority is re-quired to respond to, based on the information provided in thenotification, within the same time limitations as applied in thefirst instance.

To interpret the requirement Article 5.7 as imposing an ob-ligation to review SPS measures on one's own motion, as it were,would be administratively inefficient. Such review could bemoot for any number of reasons. The GMO in question mayhave proven to lack the economic benefits predicted for it, andthus may no longer be a competitive product; another companymay have succeeded in obtaining permission for a competingproduct that is more effective in achieving the same and similarresults, and so on. In any case, for a review to be effective, thenotifier will itself have to act to provide further information, asdiscussed above. In sum, in the GMOs context, a scheme thatpermits reapplication for permission at any time, and effectivelyinvites submission of new information with any such reapplica-tion, represents an efficient means of ensuring that precaution-ary measures are not maintained longer than is justified by lackof adequate scientific evidence

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CONCLUSIONS

Although public controversy about GMOs remains intensewithin the Union, and there are broader ethical concerns raisedby this kind of manipulation of nature, the thrust of EU-levelregulation as it is evolving from the original 1990 Directivethrough the amended directive is to base decisions about theplacing on the market of GMO products within the Union on acase-by-case scientific assessment of risk to human health and theenvironment. This is subject to the possibility of precautionaryaction, where there is not sufficient scientific knowledge availa-ble to evaluate risk in the case of some particular GMO. Thisapproach is consonant with evolving international standards, asreflecting in the FAO Statement on Biotechnology and the Car-tagena Protocol on Biosafety. The basic structure of EU regulationas reflected in the amended directive raises few serious risks ofviolating the SPS Agreement.

However, where individual member states choose to act onthe basis, in whole or in part, of ethical concerns or considera-tions (which the amended directive allows them to "take intoaccount"), and where the measure could not also be wholly justi-fied based on a scientific assessment of risk, a situation couldarise where the appropriate WTO framework would be ArticleIII of GATT and, depending upon whether ethical concernswould be found on a basis for distinguishing modified and un-modified products as "unlike" products, Article XX(a) of GATT,the "public morals" provision might also be justified.

However, one of the most promising features of the amendeddirective is the emphasis on public consultation, and publicityand transparency of reasons for decisions with respect to GMOs.Public dissemination of risk assessments and assessment reports,and consultation procedures prior to each decision, as well as inthe course of EU-level review of such decisions, may well lead toa more focused and informed public discourse about what is atstake in the GMOs debate. At the same time, such transparencyand publicity provides trading partners with additional assur-ances against the possibility that hidden protection is embeddedin case-by-case regulatory decisionmaking.

Documents

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